Trial Outcomes & Findings for QUILT-3.002: N-803 in Patients With Relapse/Refractory iNHL in Conjunction With Rituximab (NCT NCT02384954)
NCT ID: NCT02384954
Last Updated: 2024-07-03
Results Overview
Maximum Tolerated Dose level (MTD) is defined as a dose level at which \<2 out of 6 patients experienced Dose Limiting Toxicity (DLT) and that is one level below a dose that was not tolerated. Minimal Efficacious Dose (MED) is defined as a dose level which produces an Absolute Lymphocyte Count (ALC) ≥25,000/μL sustained for 14 days or a total WBC ≥35,000/μL sustained for 14 days among 2/3 or 4/6 of patients. The elevated ALC cannot be attributed to circulating lymphoma cells. Dose levels for N-803 1, 3, 6 μg/kg IV, and 6, 10, 15, 20 μg/kg subcutaneous (SQ) were used to determine the MTD or MED.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
43 participants
Primary outcome timeframe
9 months
Results posted on
2024-07-03
Participant Flow
3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
Participant milestones
| Measure |
Phase 1 Cohort 1: N-803 - IV 1 ug/kg
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 1 Cohort 2: N-803 - IV 3 ug/kg
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 1 Cohort 3: N-803 - IV 6 ug/kg
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 1 Cohort 4: N-803 - SQ 6 ug/kg
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 1 Cohort 5: N-803 - SQ 10 ug/kg
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 1 Cohort 6: N-803 - SQ 15 ug/kg
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 1 Cohort 7: N-803 - SQ 20 ug/kg
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 2 Cohort 1: Anti-CD20 mAb-sensitive N-803 - SQ 20 ug/kg
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 2 Cohort 2: Anti-CD20 mAb-refractory N-803 - SQ 20 ug/kg
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Phase 1
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
0
|
0
|
|
Phase 1
COMPLETED
|
1
|
3
|
1
|
2
|
3
|
3
|
3
|
0
|
0
|
|
Phase 1
NOT COMPLETED
|
2
|
0
|
2
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
16
|
9
|
|
Phase 2
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
13
|
6
|
|
Phase 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
3
|
Reasons for withdrawal
| Measure |
Phase 1 Cohort 1: N-803 - IV 1 ug/kg
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 1 Cohort 2: N-803 - IV 3 ug/kg
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 1 Cohort 3: N-803 - IV 6 ug/kg
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 1 Cohort 4: N-803 - SQ 6 ug/kg
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 1 Cohort 5: N-803 - SQ 10 ug/kg
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 1 Cohort 6: N-803 - SQ 15 ug/kg
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 1 Cohort 7: N-803 - SQ 20 ug/kg
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 2 Cohort 1: Anti-CD20 mAb-sensitive N-803 - SQ 20 ug/kg
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 2 Cohort 2: Anti-CD20 mAb-refractory N-803 - SQ 20 ug/kg
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Phase 1
Progressive Disease
|
2
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2
Progressive Disease
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
|
Phase 2
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Phase 2
Failure to meet continuation criteria
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
Baseline characteristics by cohort
| Measure |
Phase 1 Cohort 1: N-803 - IV 1 ug/kg
n=3 Participants
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 1 Cohort 2: N-803 - IV 3 ug/kg
n=3 Participants
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 1 Cohort 3: N-803 - IV 6 ug/kg
n=3 Participants
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 1 Cohort 4: N-803 - SQ 6 ug/kg
n=3 Participants
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 1 Cohort 5: N-803 - SQ 10 ug/kg
n=3 Participants
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 1 Cohort 6: N-803 - SQ 15 ug/kg
n=3 Participants
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 1 Cohort 7: N-803 - SQ 20 ug/kg
n=3 Participants
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 2 Cohort 1: Anti-CD20 mAb-sensitive N-803 - SQ 20 ug/kg
n=16 Participants
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 2 Cohort 2: Anti-CD20 mAb-refractory N-803 - SQ 20 ug/kg
n=9 Participants
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
Phase 1
|
58.0 years
STANDARD_DEVIATION 1.00 • n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
64.7 years
STANDARD_DEVIATION 7.37 • n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
69.3 years
STANDARD_DEVIATION 8.39 • n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
60.0 years
STANDARD_DEVIATION 4.58 • n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
65.0 years
STANDARD_DEVIATION 10.44 • n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
68.3 years
STANDARD_DEVIATION 10.21 • n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
62.0 years
STANDARD_DEVIATION 3.61 • n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
—
|
—
|
63.9 years
STANDARD_DEVIATION 7.28 • n=21 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
|
Age, Continuous
Phase 2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
59.5 years
STANDARD_DEVIATION 11.39 • n=16 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
69.1 years
STANDARD_DEVIATION 12.54 • n=9 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
63.0 years
STANDARD_DEVIATION 12.48 • n=25 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
|
Sex: Female, Male
Phase 1 · Female
|
2 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
2 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
2 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
2 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
3 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
—
|
—
|
11 Participants
n=21 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
|
Sex: Female, Male
Phase 1 · Male
|
1 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
1 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
3 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
3 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
1 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
1 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
—
|
—
|
10 Participants
n=21 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
|
Sex: Female, Male
Phase 2 · Female
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
10 Participants
n=16 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
2 Participants
n=9 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
12 Participants
n=25 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
|
Sex: Female, Male
Phase 2 · Male
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
6 Participants
n=16 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
7 Participants
n=9 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
13 Participants
n=25 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
|
Race (NIH/OMB)
Phase 1 · American Indian or Alaska Native
|
0 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
n=21 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
|
Race (NIH/OMB)
Phase 1 · Asian
|
0 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
n=21 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
|
Race (NIH/OMB)
Phase 1 · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
n=21 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
|
Race (NIH/OMB)
Phase 1 · Black or African American
|
0 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
1 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
1 Participants
n=21 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
|
Race (NIH/OMB)
Phase 1 · White
|
3 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
3 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
2 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
3 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
3 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
3 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
3 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
20 Participants
n=21 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
|
Race (NIH/OMB)
Phase 1 · More than one race
|
0 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
n=21 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
|
Race (NIH/OMB)
Phase 1 · Unknown or Not Reported
|
0 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
n=21 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
|
Race (NIH/OMB)
Phase 2 · American Indian or Alaska Native
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=16 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
n=9 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
n=25 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
|
Race (NIH/OMB)
Phase 2 · Asian
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=16 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
2 Participants
n=9 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
2 Participants
n=25 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
|
Race (NIH/OMB)
Phase 2 · Native Hawaiian or Other Pacific Islander
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=16 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
n=9 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
n=25 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
|
Race (NIH/OMB)
Phase 2 · Black or African American
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=16 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
1 Participants
n=9 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
1 Participants
n=25 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
|
Race (NIH/OMB)
Phase 2 · White
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
14 Participants
n=16 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
6 Participants
n=9 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
20 Participants
n=25 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
|
Race (NIH/OMB)
Phase 2 · More than one race
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1 Participants
n=16 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
n=9 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
1 Participants
n=25 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
|
Race (NIH/OMB)
Phase 2 · Unknown or Not Reported
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1 Participants
n=16 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
0 Participants
n=9 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
1 Participants
n=25 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
|
Patients with relapse/refractory indolent B cell non-Hodgkin lymphoma
Phase 1
|
3 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
3 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
3 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
3 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
3 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
3 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
3 Participants
n=3 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
—
|
—
|
21 Participants
n=21 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
|
Patients with relapse/refractory indolent B cell non-Hodgkin lymphoma
Phase 2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
16 Participants
n=16 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
9 Participants
n=9 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
25 Participants
n=25 Participants • 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
|
PRIMARY outcome
Timeframe: 9 monthsMaximum Tolerated Dose level (MTD) is defined as a dose level at which \<2 out of 6 patients experienced Dose Limiting Toxicity (DLT) and that is one level below a dose that was not tolerated. Minimal Efficacious Dose (MED) is defined as a dose level which produces an Absolute Lymphocyte Count (ALC) ≥25,000/μL sustained for 14 days or a total WBC ≥35,000/μL sustained for 14 days among 2/3 or 4/6 of patients. The elevated ALC cannot be attributed to circulating lymphoma cells. Dose levels for N-803 1, 3, 6 μg/kg IV, and 6, 10, 15, 20 μg/kg subcutaneous (SQ) were used to determine the MTD or MED.
Outcome measures
| Measure |
Phase 1 Cohort 7: N-803 - SQ 20 μg/kg
n=21 Participants
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 1 Cohort 2: N-803 - IV 3 ug/kg
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 1 Cohort 3: N-803 - IV 6 ug/kg
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 1 Cohort 4: N-803 - SQ 6 ug/kg
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 1 Cohort 5: N-803 - SQ 10 ug/kg
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 1 Cohort 6: N-803 - SQ 15 ug/kg
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 1 Cohort 7: N-803 - SQ 20 ug/kg
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 2 Cohort 1: Anti-CD20 mAb-sensitive N-803 - SQ 20 ug/kg
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 2 Cohort 2: Anti-CD20 mAb-refractory N-803 - SQ 20 ug/kg
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
MTD or MED of N-803: IV 1, 3, 6 μg/kg, SQ 6, 10, 15, 20 μg/kg
|
20 SQ μg/kg
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 30 days after last dose, up to 40 weeksPopulation: 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
Treatment Emergent Adverse Event is defined as any AE that begins or worsens in grade after the start of study treatment until 30 days after the last dose of study treatment or end of study period, whichever is later.
Outcome measures
| Measure |
Phase 1 Cohort 7: N-803 - SQ 20 μg/kg
n=3 Participants
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 1 Cohort 2: N-803 - IV 3 ug/kg
n=3 Participants
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 1 Cohort 3: N-803 - IV 6 ug/kg
n=3 Participants
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 1 Cohort 4: N-803 - SQ 6 ug/kg
n=3 Participants
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 1 Cohort 5: N-803 - SQ 10 ug/kg
n=3 Participants
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 1 Cohort 6: N-803 - SQ 15 ug/kg
n=3 Participants
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 1 Cohort 7: N-803 - SQ 20 ug/kg
n=3 Participants
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 2 Cohort 1: Anti-CD20 mAb-sensitive N-803 - SQ 20 ug/kg
n=16 Participants
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 2 Cohort 2: Anti-CD20 mAb-refractory N-803 - SQ 20 ug/kg
n=9 Participants
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events
Phase 1
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events
Phase 2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
16 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: 60 monthsPopulation: 3 subjects from Phase 1 cohort 7 rolled over to the Phase 2 portion of the study. All other participants in Phase 2 only enrolled in the Phase 2 portion of the study.
For Phase 1 and 2, overall response rate (ORR) will be calculated as the ratio of the number of patients who demonstrated response (CR+PR) divided by the number of patients in the Evaluable population. Response and disease progression criteria were defined by the 2007 IHP response assessments for malignant lymphoma.
Outcome measures
| Measure |
Phase 1 Cohort 7: N-803 - SQ 20 μg/kg
n=3 Participants
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 1 Cohort 2: N-803 - IV 3 ug/kg
n=3 Participants
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 1 Cohort 3: N-803 - IV 6 ug/kg
n=3 Participants
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 1 Cohort 4: N-803 - SQ 6 ug/kg
n=3 Participants
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 1 Cohort 5: N-803 - SQ 10 ug/kg
n=3 Participants
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 1 Cohort 6: N-803 - SQ 15 ug/kg
n=3 Participants
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 1 Cohort 7: N-803 - SQ 20 ug/kg
n=3 Participants
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 2 Cohort 1: Anti-CD20 mAb-sensitive N-803 - SQ 20 ug/kg
n=15 Participants
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 2 Cohort 2: Anti-CD20 mAb-refractory N-803 - SQ 20 ug/kg
n=9 Participants
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Response Rate
Phase 1
|
33 percentage of subjects
Interval 0.8 to 90.6
|
33 percentage of subjects
Interval 0.8 to 90.6
|
67 percentage of subjects
Interval 9.4 to 99.2
|
33 percentage of subjects
Interval 0.8 to 90.6
|
67 percentage of subjects
Interval 9.4 to 99.2
|
67 percentage of subjects
Interval 9.4 to 99.2
|
100 percentage of subjects
Interval 29.2 to 100.0
|
—
|
—
|
|
Overall Response Rate
Phase 2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
80 percentage of subjects
Interval 51.9 to 95.7
|
33 percentage of subjects
Interval 7.5 to 70.1
|
Adverse Events
Phase 1 Cohort 1: N-803 - IV 1 ug/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1 Cohort 2: N-803 - IV 3 ug/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1 Cohort 3: N-803 - IV 6 ug/kg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1 Cohort 4: N-803 - SQ 6 ug/kg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1 Cohort 5: N-803 - SQ 10 ug/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1 Cohort 6: N-803 - SQ 15 ug/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1 Cohort 7: N-803 - SQ 20 ug/kg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 2 Cohort 1: Anti-CD20 mAb-sensitive N-803 - SQ 20 ug/kg
Serious events: 3 serious events
Other events: 16 other events
Deaths: 0 deaths
Phase 2 Cohort 2: Anti-CD20 mAb-refractory N-803 - SQ 20 ug/kg
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1 Cohort 1: N-803 - IV 1 ug/kg
n=3 participants at risk
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 1 Cohort 2: N-803 - IV 3 ug/kg
n=3 participants at risk
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 1 Cohort 3: N-803 - IV 6 ug/kg
n=3 participants at risk
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 1 Cohort 4: N-803 - SQ 6 ug/kg
n=3 participants at risk
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 1 Cohort 5: N-803 - SQ 10 ug/kg
n=3 participants at risk
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 1 Cohort 6: N-803 - SQ 15 ug/kg
n=3 participants at risk
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 1 Cohort 7: N-803 - SQ 20 ug/kg
n=3 participants at risk
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 2 Cohort 1: Anti-CD20 mAb-sensitive N-803 - SQ 20 ug/kg
n=16 participants at risk
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 2 Cohort 2: Anti-CD20 mAb-refractory N-803 - SQ 20 ug/kg
n=9 participants at risk
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
11.1%
1/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
11.1%
1/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
11.1%
1/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
Other adverse events
| Measure |
Phase 1 Cohort 1: N-803 - IV 1 ug/kg
n=3 participants at risk
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 1 Cohort 2: N-803 - IV 3 ug/kg
n=3 participants at risk
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 1 Cohort 3: N-803 - IV 6 ug/kg
n=3 participants at risk
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 1 Cohort 4: N-803 - SQ 6 ug/kg
n=3 participants at risk
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 1 Cohort 5: N-803 - SQ 10 ug/kg
n=3 participants at risk
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 1 Cohort 6: N-803 - SQ 15 ug/kg
n=3 participants at risk
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 1 Cohort 7: N-803 - SQ 20 ug/kg
n=3 participants at risk
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 2 Cohort 1: Anti-CD20 mAb-sensitive N-803 - SQ 20 ug/kg
n=16 participants at risk
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
Phase 2 Cohort 2: Anti-CD20 mAb-refractory N-803 - SQ 20 ug/kg
n=9 participants at risk
Rituximab: Intravenous infusion 375 mg/m\^2.
N-803: Intravenous infusion for Phase 1 cohort 1, 2 and 3; subcutaneous injection for Phase 1 cohort 4, 5, 6 and 7. Phase 2 dosing was based off of the MTD determined in Phase 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
11.1%
1/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
11.1%
1/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Skin and subcutaneous tissue disorders
Precancerous skin lesion
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
66.7%
2/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
12.5%
2/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
11.1%
1/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
11.1%
1/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Eye disorders
Visual impairment
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
18.8%
3/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
3/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
66.7%
2/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
66.7%
2/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
12.5%
2/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
22.2%
2/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Gastrointestinal disorders
Diaphragmatic hernia
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
66.7%
2/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
18.8%
3/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
11.1%
1/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
66.7%
2/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
100.0%
3/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
66.7%
2/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
25.0%
4/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Gastrointestinal disorders
Oral mucosal blistering
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
12.5%
2/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
66.7%
2/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
100.0%
3/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
General disorders
Asthenia
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
General disorders
Chest discomfort
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
General disorders
Chills
|
66.7%
2/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
100.0%
3/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
66.7%
2/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
100.0%
3/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
100.0%
3/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
100.0%
3/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
100.0%
3/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
75.0%
12/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
66.7%
6/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
General disorders
Fatigue
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
66.7%
2/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
100.0%
3/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
100.0%
3/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
100.0%
3/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
43.8%
7/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
66.7%
6/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
General disorders
Gait disturbance
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
11.1%
1/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
11.1%
1/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
General disorders
Injection site reaction
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
100.0%
3/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
100.0%
3/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
100.0%
3/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
100.0%
3/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
81.2%
13/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
88.9%
8/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
General disorders
Localised oedema
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
66.7%
2/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
General disorders
Malaise
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
66.7%
2/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
22.2%
2/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
General disorders
Pain
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
66.7%
2/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
25.0%
4/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
General disorders
Peripheral swelling
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
General disorders
Pyrexia
|
66.7%
2/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
66.7%
2/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
66.7%
2/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
66.7%
2/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
100.0%
3/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
100.0%
3/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
81.2%
13/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
100.0%
9/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
General disorders
Secretion discharge
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
General disorders
Oedema
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
11.1%
1/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
General disorders
Complication associated with device
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
General disorders
Feeling abnormal
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
General disorders
Infusion site reaction
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
11.1%
1/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
General disorders
Injection site pain
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
General disorders
Injection site pruritus
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
General disorders
Injection site rash
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
11.1%
1/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
General disorders
Mass
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
66.7%
2/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
12.5%
2/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
11.1%
1/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
18.8%
3/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
22.2%
2/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
12.5%
2/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
11.1%
1/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Infections and infestations
Eye infection
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Infections and infestations
Infection
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
11.1%
1/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
66.7%
2/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
25.0%
4/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
3/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
66.7%
2/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
66.7%
2/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
12.5%
2/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
11.1%
1/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
11.1%
1/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
11.1%
1/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
37.5%
6/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
3/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
66.7%
2/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
66.7%
2/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
11.1%
1/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
66.7%
2/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Investigations
Lymphocyte count decreased
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
66.7%
2/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
22.2%
2/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
11.1%
1/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Investigations
White blood cell count decreased
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Investigations
Biopsy skin
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Investigations
Weight decreased
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
66.7%
2/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
11.1%
1/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
11.1%
1/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
11.1%
1/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
66.7%
2/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
12.5%
2/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
3/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
18.8%
3/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
11.1%
1/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Metabolism and nutrition disorders
Musculoskeletal pain
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
18.8%
3/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
11.1%
1/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
22.2%
2/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
11.1%
1/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Eye disorders
Eye irritation
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Psychiatric disorders
Depression
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
22.2%
2/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Psychiatric disorders
Stress
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
11.1%
1/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
66.7%
2/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
66.7%
2/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
66.7%
2/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
22.2%
2/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dysaesthesia pharynx
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
66.7%
2/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
22.2%
2/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
11.1%
1/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
22.2%
2/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
11.1%
1/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Reproductive system and breast disorders
Oedema genital
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
11.1%
1/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Reproductive system and breast disorders
Ovarian enlargement
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
11.1%
1/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
3/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
11.1%
1/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
11.1%
1/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Surgical and medical procedures
Papilloma excision
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Surgical and medical procedures
Catheter removal
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Surgical and medical procedures
Foot operation
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Surgical and medical procedures
Injection
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Vascular disorders
Hot flush
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
66.7%
2/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
66.7%
2/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
66.7%
2/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
33.3%
1/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/3 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
6.2%
1/16 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
0.00%
0/9 • All AEs and SAEs were to be reported within 30 days of the last dose of study treatment, regardless of attribution, up to 40 weeks. All deaths were followed during the disease progression and survival follow-up period, up to 42 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place