Trial Outcomes & Findings for SARC024: A Blanket Protocol to Study Oral Regorafenib in Patients With Selected Sarcoma Subtypes (NCT NCT02048371)
NCT ID: NCT02048371
Last Updated: 2023-11-07
Results Overview
The progression-free survival is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. Cohort A (liposarcoma) and Cohort B (osteosarcoma). PFS will be evaluated according to RECIST (Response Evaluation Criteria In Solid Tumors) 1.1, where a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
131 participants
Primary outcome timeframe
up to 3 years
Results posted on
2023-11-07
Participant Flow
Study enrollment ended early due to slow enrollment.
Participant milestones
| Measure |
Cohort A: Liposarcoma
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort A: Liposarcoma, Placebo
21 days on and 7 days off
Placebo
Placebo: 21 days on and 7 days off
|
Cohort A: Liposarcoma Crossover
Those patients who started on placebo and crossed over to active drug. Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort B: Osteosarcoma
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort B: Osteosarcoma, Placebo
21 days on and 7 days off
Placebo
Placebo: 21 days on and 7 days off
|
Cohort B: Osteosarcoma Crossover
Patients who started on placebo and crossed over to active drug.
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort C: Ewing Sarcoma
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort D: Rhabdomyosarcoma
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort E: Mesenchymal Chondrosarcoma
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
24
|
9
|
15
|
22
|
9
|
11
|
30
|
10
|
1
|
|
Overall Study
COMPLETED
|
17
|
1
|
9
|
11
|
3
|
8
|
22
|
6
|
1
|
|
Overall Study
NOT COMPLETED
|
7
|
8
|
6
|
11
|
6
|
3
|
8
|
4
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SARC024: A Blanket Protocol to Study Oral Regorafenib in Patients With Selected Sarcoma Subtypes
Baseline characteristics by cohort
| Measure |
Cohort A: Liposarcoma
n=24 Participants
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort A: Liposarcoma, Placebo
n=24 Participants
21 days on and 7 days off
Placebo
Placebo: 21 days on and 7 days off
|
Cohort B: Osteosarcoma
n=22 Participants
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort B: Osteosarcoma, Placebo
n=20 Participants
21 days on and 7 days off
Placebo
Placebo: 21 days on and 7 days off
|
Cohort C: Ewing Sarcoma
n=30 Participants
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort D: Rhabdomyosarcoma
n=10 Participants
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort E: Mesenchymal Chondrosarcoma
n=1 Participants
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Total
n=131 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
102 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
25 Participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
57 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
74 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
10 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
114 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
11 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
11 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
99 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: up to 3 yearsThe progression-free survival is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. Cohort A (liposarcoma) and Cohort B (osteosarcoma). PFS will be evaluated according to RECIST (Response Evaluation Criteria In Solid Tumors) 1.1, where a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Cohort A: Liposarcoma
n=24 Participants
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort A: Liposarcoma, Placebo
n=24 Participants
21 days on and 7 days off
Placebo
Placebo: 21 days on and 7 days off
|
Cohort B: Osteosarcoma
n=22 Participants
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort B: Osteosarcoma, Placebo
n=20 Participants
21 days on and 7 days off
Placebo
Placebo: 21 days on and 7 days off
|
Cohort C: Ewing Sarcoma
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort D: Rhabdomyosarcoma
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort E: Mesenchymal Chondrosarcoma
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
|---|---|---|---|---|---|---|---|
|
Progression-free Survival (PFS). Cohort A and Cohort B
|
1.87 months
Interval 0.92 to 3.67
|
2.07 months
Interval 1.64 to 3.44
|
3.6 months
Interval 2.0 to 7.6
|
1.7 months
Interval 1.2 to 1.8
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: up to 16 weeksThe progression-free survival is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. Cohort C (Ewing/Ewing-like sarcoma). PFS will be evaluated according to RECIST (Response Evaluation Criteria In Solid Tumors) 1.1.
Outcome measures
| Measure |
Cohort A: Liposarcoma
n=30 Participants
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort A: Liposarcoma, Placebo
n=10 Participants
21 days on and 7 days off
Placebo
Placebo: 21 days on and 7 days off
|
Cohort B: Osteosarcoma
n=1 Participants
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort B: Osteosarcoma, Placebo
21 days on and 7 days off
Placebo
Placebo: 21 days on and 7 days off
|
Cohort C: Ewing Sarcoma
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort D: Rhabdomyosarcoma
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort E: Mesenchymal Chondrosarcoma
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
|---|---|---|---|---|---|---|---|
|
Progression-free Survival (PFS). Cohort C, Cohort D, and Cohort E
|
3.4 months
Interval 1.7 to 3.7
|
1.82 months
Interval 1.58 to
The upper limit of the CI is below the level of detection.
|
NA months
There is only one participant, so statistics cannot be calculated.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 3 yearsCommon Toxicity Criteria, also referred to as the Common Terminology Criteria for Adverse Events (CTCAE), is a standardized classification of side effects used in assessing drugs for cancer therapy. Cohorts A, B, C, and D.
Outcome measures
| Measure |
Cohort A: Liposarcoma
n=24 Participants
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort A: Liposarcoma, Placebo
n=24 Participants
21 days on and 7 days off
Placebo
Placebo: 21 days on and 7 days off
|
Cohort B: Osteosarcoma
n=22 Participants
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort B: Osteosarcoma, Placebo
n=20 Participants
21 days on and 7 days off
Placebo
Placebo: 21 days on and 7 days off
|
Cohort C: Ewing Sarcoma
n=30 Participants
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort D: Rhabdomyosarcoma
n=10 Participants
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort E: Mesenchymal Chondrosarcoma
n=1 Participants
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
|---|---|---|---|---|---|---|---|
|
The Number of Participants With Reported CTCAE (Common Terminology Criteria for Adverse Events) Version 4.03 Adverse Events. All Cohorts.
|
12 Participants
|
15 Participants
|
6 Participants
|
9 Participants
|
6 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 3 yearsThe overall response rate (ORR) is the percentage of patients whose cancer shrinks or disappears after treatment. ORR will be evaluated according to RECIST (Response Evaluation Criteria In Solid Tumors) 1.1
Outcome measures
| Measure |
Cohort A: Liposarcoma
n=24 Participants
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort A: Liposarcoma, Placebo
n=24 Participants
21 days on and 7 days off
Placebo
Placebo: 21 days on and 7 days off
|
Cohort B: Osteosarcoma
n=22 Participants
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort B: Osteosarcoma, Placebo
n=20 Participants
21 days on and 7 days off
Placebo
Placebo: 21 days on and 7 days off
|
Cohort C: Ewing Sarcoma
n=30 Participants
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort D: Rhabdomyosarcoma
n=10 Participants
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort E: Mesenchymal Chondrosarcoma
n=1 Participants
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
|---|---|---|---|---|---|---|---|
|
Overall Response Rate (ORR). All Cohorts.
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 3 yearsPopulation: Participants who started on placebo in Cohorts A and B, then crossed over to active drug after progression.
The progression-free survival is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.
Outcome measures
| Measure |
Cohort A: Liposarcoma
n=15 Participants
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort A: Liposarcoma, Placebo
n=11 Participants
21 days on and 7 days off
Placebo
Placebo: 21 days on and 7 days off
|
Cohort B: Osteosarcoma
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort B: Osteosarcoma, Placebo
21 days on and 7 days off
Placebo
Placebo: 21 days on and 7 days off
|
Cohort C: Ewing Sarcoma
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort D: Rhabdomyosarcoma
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort E: Mesenchymal Chondrosarcoma
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
|---|---|---|---|---|---|---|---|
|
Progression-free Survival (PFS), Cohorts A and B, After Crossover.
|
1.68 months
Interval 0.92 to 5.59
|
5.78 months
Interval 3.55 to
The upper limit of the CI is below the level of detection.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 3 yearsPopulation: Participants who started on placebo then crossed over to active drug.
The response rate (RR) is the percentage of patients whose cancer shrinks or disappears after treatment.
Outcome measures
| Measure |
Cohort A: Liposarcoma
n=15 Participants
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort A: Liposarcoma, Placebo
n=11 Participants
21 days on and 7 days off
Placebo
Placebo: 21 days on and 7 days off
|
Cohort B: Osteosarcoma
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort B: Osteosarcoma, Placebo
21 days on and 7 days off
Placebo
Placebo: 21 days on and 7 days off
|
Cohort C: Ewing Sarcoma
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort D: Rhabdomyosarcoma
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort E: Mesenchymal Chondrosarcoma
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
|---|---|---|---|---|---|---|---|
|
Response Rate (RR), Cohorts A and B, After Crossover.
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 3 yearsPopulation: Participants who crossed over to active drug after placebo.
Time to tumor progression (TTP) is the length of time from the date of diagnosis or the start of treatment for a disease until the disease starts to get worse or spread to other parts of the body.
Outcome measures
| Measure |
Cohort A: Liposarcoma
n=15 Participants
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort A: Liposarcoma, Placebo
n=11 Participants
21 days on and 7 days off
Placebo
Placebo: 21 days on and 7 days off
|
Cohort B: Osteosarcoma
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort B: Osteosarcoma, Placebo
21 days on and 7 days off
Placebo
Placebo: 21 days on and 7 days off
|
Cohort C: Ewing Sarcoma
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort D: Rhabdomyosarcoma
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort E: Mesenchymal Chondrosarcoma
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
|---|---|---|---|---|---|---|---|
|
Time to Tumor Progression (TTP), Cohorts A and B, After Crossover.
|
1.76 months
Interval 0.92 to
The upper limit of CI is below the level of detection.
|
5.78 months
Interval 3.55 to
The upper limit of CI is below the level of detection.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 3 yearsPopulation: Participants who started on placebo and crossed over to active drug after progression.
Overall survival (OS) is the length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.
Outcome measures
| Measure |
Cohort A: Liposarcoma
n=15 Participants
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort A: Liposarcoma, Placebo
n=11 Participants
21 days on and 7 days off
Placebo
Placebo: 21 days on and 7 days off
|
Cohort B: Osteosarcoma
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort B: Osteosarcoma, Placebo
21 days on and 7 days off
Placebo
Placebo: 21 days on and 7 days off
|
Cohort C: Ewing Sarcoma
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort D: Rhabdomyosarcoma
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort E: Mesenchymal Chondrosarcoma
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
|---|---|---|---|---|---|---|---|
|
Overall Survival (OS). Cohorts A and B, After Crossover.
|
7.98 months
Interval 3.98 to
The upper limit of the CI is below the level of detection.
|
16.11 months
Interval 8.54 to
The upper limit of the CI is below the level of detection.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 3 yearsPopulation: Participants who started on placebo and crossed over to active drug upon progression.
Disease-specific survival refers to the percentage of people in a study or treatment group who have not died from a specific disease in a defined period of time.
Outcome measures
| Measure |
Cohort A: Liposarcoma
n=15 Participants
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort A: Liposarcoma, Placebo
n=11 Participants
21 days on and 7 days off
Placebo
Placebo: 21 days on and 7 days off
|
Cohort B: Osteosarcoma
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort B: Osteosarcoma, Placebo
21 days on and 7 days off
Placebo
Placebo: 21 days on and 7 days off
|
Cohort C: Ewing Sarcoma
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort D: Rhabdomyosarcoma
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort E: Mesenchymal Chondrosarcoma
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
|---|---|---|---|---|---|---|---|
|
Disease Specific Survival (DSS). Cohorts A and B, After Crossover.
|
7.98 months
Interval 3.98 to
The upper limit of the CI is below the level of detection.
|
16.11 months
Interval 8.54 to
The upper limit of the CI is below the level of detection.
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Cohort A: Liposarcoma
Serious events: 28 serious events
Other events: 26 other events
Deaths: 25 deaths
Cohort A: Liposarcoma, Placebo
Serious events: 7 serious events
Other events: 8 other events
Deaths: 7 deaths
Cohort B: Osteosarcoma
Serious events: 24 serious events
Other events: 26 other events
Deaths: 26 deaths
Cohort B: Osteosarcoma, Placebo
Serious events: 7 serious events
Other events: 6 other events
Deaths: 8 deaths
Cohort C: Ewing Sarcoma
Serious events: 21 serious events
Other events: 22 other events
Deaths: 17 deaths
Cohort D: Rhabdomyosarcoma
Serious events: 4 serious events
Other events: 2 other events
Deaths: 4 deaths
Cohort D: Pediatric
Serious events: 2 serious events
Other events: 1 other events
Deaths: 2 deaths
Cohort E: Mesenchymal Chondrosarcoma
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A: Liposarcoma
n=39 participants at risk
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort A: Liposarcoma, Placebo
n=9 participants at risk
21 days on and 7 days off
Placebo
Placebo: 21 days on and 7 days off
|
Cohort B: Osteosarcoma
n=33 participants at risk
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort B: Osteosarcoma, Placebo
n=9 participants at risk
21 days on and 7 days off
Placebo
Placebo: 21 days on and 7 days off
|
Cohort C: Ewing Sarcoma
n=30 participants at risk
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort D: Rhabdomyosarcoma
n=6 participants at risk
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort D: Pediatric
n=4 participants at risk
Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib:
Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort E: Mesenchymal Chondrosarcoma
n=1 participants at risk
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
2.6%
1/39 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Blood and lymphatic system disorders
Anemia
|
10.3%
4/39 • Number of events 4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
33.3%
3/9 • Number of events 3 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
16.7%
1/6 • Number of events 3 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Blood and lymphatic system disorders
Low Phosphate
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Investigations
Creatinine Increased
|
2.6%
1/39 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Blood and lymphatic system disorders
Elevated AST/SGOT
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.3%
1/30 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Blood and lymphatic system disorders
Amylase Elevation
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
16.7%
1/6 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Blood and lymphatic system disorders
Decreased WBC
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
16.7%
1/6 • Number of events 3 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Blood and lymphatic system disorders
Hyperfibrinolysis
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
33.3%
2/6 • Number of events 3 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Blood and lymphatic system disorders
Lipase Elevation
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
16.7%
1/6 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
16.7%
1/6 • Number of events 5 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Endocrine disorders
Alkaline Phosphatase Elevated
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.0%
1/33 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Eye disorders
Loss of Vision, Left Eye
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.0%
1/33 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Ear and labyrinth disorders
Vision Loss, Right Eye
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.0%
1/33 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Gastrointestinal disorders
Abdominal Pain
|
10.3%
4/39 • Number of events 4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
6.1%
2/33 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.3%
1/30 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Gastrointestinal disorders
C/W Bowel Obstruction
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Gastrointestinal disorders
Diarrhea
|
2.6%
1/39 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.0%
1/33 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.3%
1/30 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Gastrointestinal disorders
Nausea
|
2.6%
1/39 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
22.2%
2/9 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.3%
1/30 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Gastrointestinal disorders
Constipation
|
2.6%
1/39 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Gastrointestinal disorders
Dysphagia
|
2.6%
1/39 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Gastrointestinal disorders
Gastric Hemorrhage
|
2.6%
1/39 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Gastrointestinal disorders
Lower Gastric Hemorrhage
|
2.6%
1/39 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Gastrointestinal disorders
Mucositis Oral
|
2.6%
1/39 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.0%
1/33 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.3%
1/30 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Gastrointestinal disorders
Vomiting
|
2.6%
1/39 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
16.7%
1/6 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
25.0%
1/4 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Gastrointestinal disorders
Colonic Perforation
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.0%
1/33 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
General disorders
Death NOS
|
5.1%
2/39 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.3%
1/30 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
General disorders
Fatigue
|
12.8%
5/39 • Number of events 5 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.3%
1/30 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
General disorders
Pain
|
5.1%
2/39 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
6.7%
2/30 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
33.3%
2/6 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
General disorders
Failure to Thrive
|
2.6%
1/39 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
General disorders
Fever
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
6.1%
2/33 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
General disorders
Weakness
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
General disorders
Pain Crisis
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.3%
1/30 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Hepatobiliary disorders
Gallbladder Pain
|
2.6%
1/39 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Infections and infestations
Sepsis
|
2.6%
1/39 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Infections and infestations
Wound Infection
|
2.6%
1/39 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.0%
1/33 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.3%
1/30 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Infections and infestations
C. Difficile Infection
|
2.6%
1/39 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Infections and infestations
Jaw Infection
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.0%
1/33 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Infections and infestations
Peri-Prosthetic Joint Infection, Left Knee
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.0%
1/33 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Infections and infestations
Soft Tissue Infection
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.0%
1/33 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Investigations
Activated partial Thromboplastin Time Prolonged
|
2.6%
1/39 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Investigations
Jaundice
|
2.6%
1/39 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Investigations
Lipase Increased
|
7.7%
3/39 • Number of events 3 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
12.1%
4/33 • Number of events 4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.3%
1/30 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Investigations
Lymphocyte Count Decreased
|
5.1%
2/39 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.0%
1/33 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
16.7%
1/6 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
25.0%
1/4 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Investigations
Weight Loss
|
2.6%
1/39 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.0%
1/33 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.0%
1/33 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.3%
1/30 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
25.0%
1/4 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.0%
1/33 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Investigations
Multiple Drug Overdose
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.0%
1/33 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
6.1%
2/33 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
16.7%
1/6 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
25.0%
1/4 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Musculoskeletal and connective tissue disorders
Right hip pain
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
16.7%
1/6 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Investigations
Hypophosphatemia
|
7.7%
3/39 • Number of events 3 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
22.2%
2/9 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
15.2%
5/33 • Number of events 7 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
30.0%
9/30 • Number of events 14 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
16.7%
1/6 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Investigations
Neutrophil Count Decreased
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.3%
1/30 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
25.0%
1/4 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Investigations
White Blood Cell Decreased
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.3%
1/30 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
25.0%
1/4 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Metabolism and nutrition disorders
Anorexia
|
5.1%
2/39 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Metabolism and nutrition disorders
Dehyrdation
|
2.6%
1/39 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
2.6%
1/39 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.1%
2/39 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.0%
1/33 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.3%
1/30 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.6%
1/39 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.0%
1/33 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.6%
1/39 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.1%
2/39 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.0%
1/33 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
6.1%
2/33 • Number of events 3 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.3%
1/30 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fungating Tumor
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Progressive Disease
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor Pain
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Nervous system disorders
Syncope
|
5.1%
2/39 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Nervous system disorders
Pinched nerve
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.3%
1/30 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.3%
1/30 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
2.6%
1/39 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Renal and urinary disorders
Urinary Tract Infection
|
2.6%
1/39 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.0%
1/33 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
6.1%
2/33 • Number of events 3 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.3%
1/30 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.3%
1/30 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
16.7%
1/6 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Skin and subcutaneous tissue disorders
Blister on heel
|
2.6%
1/39 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.3%
4/39 • Number of events 5 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
9.1%
3/33 • Number of events 5 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.3%
1/30 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
16.7%
1/6 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar Erythrodysesthesia Syndrome
|
5.1%
2/39 • Number of events 4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.0%
1/33 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
22.2%
2/9 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.0%
1/33 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Surgical and medical procedures
Postoperative pain
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.0%
1/33 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Surgical and medical procedures
Composite resection
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
16.7%
1/6 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Vascular disorders
Hypertension
|
12.8%
5/39 • Number of events 8 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
22.2%
2/9 • Number of events 5 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
12.1%
4/33 • Number of events 4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
6.7%
2/30 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Vascular disorders
Pulmonary embolism
|
2.6%
1/39 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Vascular disorders
Thromboembolic event
|
5.1%
2/39 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.3%
1/30 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Vascular disorders
Hematoma
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.3%
1/30 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
Other adverse events
| Measure |
Cohort A: Liposarcoma
n=39 participants at risk
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort A: Liposarcoma, Placebo
n=9 participants at risk
21 days on and 7 days off
Placebo
Placebo: 21 days on and 7 days off
|
Cohort B: Osteosarcoma
n=33 participants at risk
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort B: Osteosarcoma, Placebo
n=9 participants at risk
21 days on and 7 days off
Placebo
Placebo: 21 days on and 7 days off
|
Cohort C: Ewing Sarcoma
n=30 participants at risk
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort D: Rhabdomyosarcoma
n=6 participants at risk
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort D: Pediatric
n=4 participants at risk
Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib:
Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
Cohort E: Mesenchymal Chondrosarcoma
n=1 participants at risk
Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
Regorafenib
Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Blood and lymphatic system disorders
Hypertension
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
30.3%
10/33 • Number of events 19 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 12 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Endocrine disorders
Alkaline Phosphatase Elevated
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
6.1%
2/33 • Number of events 3 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
22.2%
2/9 • Number of events 4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Eye disorders
Blurred vision
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Eye disorders
Vision Loss, Right Eye
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
6.1%
2/33 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.3%
1/30 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
22.2%
2/9 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
9.1%
3/33 • Number of events 3 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
16.7%
5/30 • Number of events 7 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Gastrointestinal disorders
Nausea
|
7.7%
3/39 • Number of events 3 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
18.2%
6/33 • Number of events 7 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
22.2%
2/9 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
20.0%
6/30 • Number of events 7 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
12.1%
4/33 • Number of events 5 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.3%
1/30 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
9.1%
3/33 • Number of events 4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
10.0%
3/30 • Number of events 3 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
General disorders
Fatigue
|
7.7%
3/39 • Number of events 3 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
22.2%
2/9 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
9.1%
3/33 • Number of events 4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
10.0%
3/30 • Number of events 3 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
General disorders
Fever
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
22.2%
2/9 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
9.1%
3/33 • Number of events 3 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.3%
1/30 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.0%
1/33 • Number of events 3 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.3%
1/30 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
6.1%
2/33 • Number of events 4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
6.7%
2/30 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Investigations
Weight loss
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.3%
1/30 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Investigations
Hypophosphatemina
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
6.7%
2/30 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Metabolism and nutrition disorders
Anorexia
|
5.1%
2/39 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.3%
1/30 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
22.2%
2/9 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.1%
2/39 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Investigations
Hypokalemia
|
5.1%
2/39 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.3%
1/30 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Metabolism and nutrition disorders
Hypomagesemia
|
7.7%
3/39 • Number of events 3 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
6.1%
2/33 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Metabolism and nutrition disorders
Generalized muscle weakness
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Metabolism and nutrition disorders
Arthralgia
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
3.3%
1/30 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Nervous system disorders
Headache
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
20.0%
6/30 • Number of events 6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.1%
2/39 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
16.7%
1/6 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Bloody cough
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
11.1%
1/9 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
17.9%
7/39 • Number of events 7 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
27.3%
9/33 • Number of events 11 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
33.3%
10/30 • Number of events 15 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
25.0%
1/4 • Number of events 1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Skin and subcutaneous tissue disorders
HFS (hand and foot syndrome)
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
6.7%
2/30 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
6.1%
2/33 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
10.0%
3/30 • Number of events 3 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Skin and subcutaneous tissue disorders
Palmar erythema
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/33 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
6.7%
2/30 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/39 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
6.1%
2/33 • Number of events 3 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/30 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/6 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
|
Vascular disorders
Hypertension
|
15.4%
6/39 • Number of events 7 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
44.4%
4/9 • Number of events 9 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
15.2%
5/33 • Number of events 8 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
55.6%
5/9 • Number of events 12 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
16.7%
5/30 • Number of events 5 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
33.3%
2/6 • Number of events 2 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/4 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
0.00%
0/1 • Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or until serious adverse events resolve (up to 3 years).
Participants who crossed over are included in the total number at risk in the treatment arm for each Cohort as those participants were receiving treatment at time of adverse event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place