Trial Outcomes & Findings for Phase 1/2a Dose Escalation Study in Participants With CLL, SLL, or NHL (NCT NCT01994382)
NCT ID: NCT01994382
Last Updated: 2022-04-05
Results Overview
DLT was defined as any of the following toxicities, possibly or probably related to cerdulatinib, and clinically significant (in the judgement of Investigator): -Febrile neutropenia (absolute neutrophil count \<1000/microliter \[μL\] and temperature ≥38.5°Celcius). -Grade 4 neutropenia for \>5 days. -Grade 4 thrombocytopenia with or without bleeding. -Grade 3 thrombocytopenia with bleeding. -Grade 4 anemia, unexplained by underlying disease. -Grade 3 or greater nausea, vomiting, or diarrhea if persistent despite optimal antiemetic or anti-diarrheal therapy. -Grade 3 or greater increase in transaminases lasting \>5 days. -Grade 3 or greater fatigue persisting \>7 days in absence of any other underlying cause. -Any other Grade 3 or greater non-hematologic toxicity (except fatigue as noted above) considered clinically significant by Investigator. -Toxicity of any grade resulting in dose delay of \>7 days. -Toxicity resulting in study drug discontinuation prior to completion of Cycle 1.
COMPLETED
PHASE1/PHASE2
260 participants
Baseline up to Day 28 of Cycle 1 (cycle = 21 days or 28 days)
2022-04-05
Participant Flow
This was an open-label study with 2 phases.
Phase 1: dose-escalation portion of study, participants received doses of cerdulatinib at assigned regimen. Phase 2a: participants were enrolled into cohorts based on cancer type and received single agent cerdulatinib except for 1 cohort, participants received cerdulatinib+rituximab. Three participants in Phase 1 rolled over to Phase 2; their data are included in respective arms in both phases. Therefore, the data are included twice in the Totals for Participant Flow \& Baseline Characteristics.
Participant milestones
| Measure |
Phase 1: Cerdulatinib 15 Milligrams (mg) Once Daily (QD)
Participants received oral cerdulatinib at 15 mg QD starting on Day 1 in 21-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 30 mg QD
Participants received oral cerdulatinib at 30 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 45 mg QD
Participants received oral cerdulatinib at 45 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 15 mg Twice Daily (BID)
Participants received oral cerdulatinib at 15 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 40 mg QD
Participants received oral cerdulatinib at 40 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 20 mg BID
Participants received oral cerdulatinib at 20 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 50 mg QD
Participants received oral cerdulatinib at 50 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 65 mg QD
Participants received oral cerdulatinib at 65 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 100 mg QD
Participants received oral cerdulatinib at 100 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 45 mg BID
Participants received oral cerdulatinib at 45 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 2a: Cerdulatinib (FL Cohort)
Participants with follicular lymphoma (FL) received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
|
Phase 2a: Cerdulatinib (MZL/WM Cohort)
Participants with marginal zone lymphoma/Waldenström's macroglobulinemia (MZL/WM) received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
|
Phase 2a: Cerdulatinib Plus Rituximab (FL Cohort)
Participants with FL received oral cerdulatinib at starting doses of 30 or 20 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. Participants also received intravenous (IV) injections of rituximab 375 milligrams (mg)/square meter (m\^2) on Days 1, 8, 15, and 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, and 10.
|
Phase 2a: Cerdulatinib (aNHL Cohort)
Participants with aggressive non-Hodgkin lymphoma (aNHL) received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
|
Phase 2a: Cerdulatinib (CLL/SLL Cohort)
Participants with chronic lymphocytic leukemia/small cell lymphocytic lymphoma (CLL/SLL) received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
|
Phase 2a: Cerdulatinib (PTCL Cohort)
Participants with peripheral T-cell lymphoma (PTCL) received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
|
Phase 2a: Cerdulatinib (CTCL Cohort)
Participants with cutaneous T-cell lymphoma (CTCL) received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
7
|
3
|
3
|
3
|
4
|
6
|
3
|
5
|
42
|
12
|
26
|
6
|
28
|
65
|
41
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
3
|
6
|
7
|
3
|
3
|
3
|
4
|
6
|
3
|
5
|
42
|
12
|
26
|
6
|
28
|
65
|
41
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
7
|
3
|
3
|
3
|
4
|
6
|
3
|
5
|
42
|
12
|
26
|
6
|
28
|
65
|
41
|
Reasons for withdrawal
| Measure |
Phase 1: Cerdulatinib 15 Milligrams (mg) Once Daily (QD)
Participants received oral cerdulatinib at 15 mg QD starting on Day 1 in 21-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 30 mg QD
Participants received oral cerdulatinib at 30 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 45 mg QD
Participants received oral cerdulatinib at 45 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 15 mg Twice Daily (BID)
Participants received oral cerdulatinib at 15 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 40 mg QD
Participants received oral cerdulatinib at 40 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 20 mg BID
Participants received oral cerdulatinib at 20 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 50 mg QD
Participants received oral cerdulatinib at 50 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 65 mg QD
Participants received oral cerdulatinib at 65 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 100 mg QD
Participants received oral cerdulatinib at 100 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 45 mg BID
Participants received oral cerdulatinib at 45 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 2a: Cerdulatinib (FL Cohort)
Participants with follicular lymphoma (FL) received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
|
Phase 2a: Cerdulatinib (MZL/WM Cohort)
Participants with marginal zone lymphoma/Waldenström's macroglobulinemia (MZL/WM) received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
|
Phase 2a: Cerdulatinib Plus Rituximab (FL Cohort)
Participants with FL received oral cerdulatinib at starting doses of 30 or 20 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. Participants also received intravenous (IV) injections of rituximab 375 milligrams (mg)/square meter (m\^2) on Days 1, 8, 15, and 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, and 10.
|
Phase 2a: Cerdulatinib (aNHL Cohort)
Participants with aggressive non-Hodgkin lymphoma (aNHL) received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
|
Phase 2a: Cerdulatinib (CLL/SLL Cohort)
Participants with chronic lymphocytic leukemia/small cell lymphocytic lymphoma (CLL/SLL) received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
|
Phase 2a: Cerdulatinib (PTCL Cohort)
Participants with peripheral T-cell lymphoma (PTCL) received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
|
Phase 2a: Cerdulatinib (CTCL Cohort)
Participants with cutaneous T-cell lymphoma (CTCL) received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Informed consent withdrawn
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Progressive disease
|
3
|
4
|
4
|
3
|
2
|
3
|
3
|
6
|
2
|
2
|
13
|
8
|
7
|
3
|
6
|
44
|
28
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
1
|
1
|
0
|
1
|
4
|
2
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
15
|
2
|
7
|
3
|
17
|
6
|
3
|
|
Overall Study
Other than specified
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
2
|
0
|
0
|
4
|
4
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
0
|
2
|
0
|
4
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Participants rolled over into expanded access program (NCT04757259)
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
7
|
0
|
0
|
3
|
2
|
|
Overall Study
Protocol violation/noncompliance
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
2
|
|
Overall Study
Rolled over to Phase 2a
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Phase 1/2a Dose Escalation Study in Participants With CLL, SLL, or NHL
Baseline characteristics by cohort
| Measure |
Phase 1: Cerdulatinib 15 mg QD
n=3 Participants
Participants received oral cerdulatinib at 15 mg QD starting on Day 1 in 21-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 30 mg QD
n=6 Participants
Participants received oral cerdulatinib at 30 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 45 mg QD
n=7 Participants
Participants received oral cerdulatinib at 45 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 15 mg BID
n=3 Participants
Participants received oral cerdulatinib at 15 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 40 mg QD
n=3 Participants
Participants received oral cerdulatinib at 40 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 20 mg BID
n=3 Participants
Participants received oral cerdulatinib at 20 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 50 mg QD
n=4 Participants
Participants received oral cerdulatinib at 50 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 65 mg QD
n=6 Participants
Participants received oral cerdulatinib at 65 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 100 mg QD
n=3 Participants
Participants received oral cerdulatinib at 100 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 45 mg BID
n=5 Participants
Participants received oral cerdulatinib at 45 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 2a: Cerdulatinib (FL Cohort)
n=42 Participants
Participants with FL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
|
Phase 2a: Cerdulatinib (MZL/WM Cohort)
n=12 Participants
Participants with MZL/WM received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
|
Phase 2a: Cerdulatinib Plus Rituximab (FL Cohort)
n=26 Participants
Participants with FL received oral cerdulatinib at starting doses of 30 or 20 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID. Participants also received IV injections of rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, and 10.
|
Phase 2a: Cerdulatinib (aNHL Cohort)
n=6 Participants
Participants with aNHL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
|
Phase 2a: Cerdulatinib (CLL/SLL Cohort)
n=28 Participants
Participants with CLL/SLL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
|
Phase 2a: Cerdulatinib (PTCL Cohort)
n=65 Participants
Participants with PTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
|
Phase 2a: Cerdulatinib (CTCL Cohort)
n=41 Participants
Participants with CTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
|
Total
n=263 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=62 Participants
|
23 Participants
n=95 Participants
|
7 Participants
n=129 Participants
|
13 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
8 Participants
n=24 Participants
|
33 Participants
n=135 Participants
|
21 Participants
n=136 Participants
|
120 Participants
n=44 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
5 Participants
n=40 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=62 Participants
|
19 Participants
n=95 Participants
|
5 Participants
n=129 Participants
|
13 Participants
n=36 Participants
|
4 Participants
n=36 Participants
|
20 Participants
n=24 Participants
|
32 Participants
n=135 Participants
|
20 Participants
n=136 Participants
|
143 Participants
n=44 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=62 Participants
|
16 Participants
n=95 Participants
|
4 Participants
n=129 Participants
|
9 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
12 Participants
n=24 Participants
|
24 Participants
n=135 Participants
|
18 Participants
n=136 Participants
|
97 Participants
n=44 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
5 Participants
n=40 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=62 Participants
|
26 Participants
n=95 Participants
|
8 Participants
n=129 Participants
|
17 Participants
n=36 Participants
|
5 Participants
n=36 Participants
|
16 Participants
n=24 Participants
|
41 Participants
n=135 Participants
|
23 Participants
n=136 Participants
|
166 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=62 Participants
|
2 Participants
n=95 Participants
|
1 Participants
n=129 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
6 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
13 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
6 Participants
n=40 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=62 Participants
|
37 Participants
n=95 Participants
|
10 Participants
n=129 Participants
|
24 Participants
n=36 Participants
|
5 Participants
n=36 Participants
|
26 Participants
n=24 Participants
|
53 Participants
n=135 Participants
|
37 Participants
n=136 Participants
|
232 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=62 Participants
|
3 Participants
n=95 Participants
|
1 Participants
n=129 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
6 Participants
n=135 Participants
|
3 Participants
n=136 Participants
|
18 Participants
n=44 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=62 Participants
|
1 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
3 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
2 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
6 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
1 Participants
n=95 Participants
|
1 Participants
n=129 Participants
|
2 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
3 Participants
n=24 Participants
|
10 Participants
n=135 Participants
|
11 Participants
n=136 Participants
|
29 Participants
n=44 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
6 Participants
n=40 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=62 Participants
|
36 Participants
n=95 Participants
|
11 Participants
n=129 Participants
|
22 Participants
n=36 Participants
|
6 Participants
n=36 Participants
|
23 Participants
n=24 Participants
|
48 Participants
n=135 Participants
|
24 Participants
n=136 Participants
|
211 Participants
n=44 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
2 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
5 Participants
n=135 Participants
|
4 Participants
n=136 Participants
|
13 Participants
n=44 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 28 of Cycle 1 (cycle = 21 days or 28 days)Population: The Safety Analysis Population included participants who received at least 1 dose of study drug. Only data from participants in Phase 1 cohorts (arms) were applicable and evaluated for this Outcome Measure. Evaluable participants for this Outcome Measure must have received 80% of doses in Cycle 1 or withdrawn from study drug due to drug-related toxicity.
DLT was defined as any of the following toxicities, possibly or probably related to cerdulatinib, and clinically significant (in the judgement of Investigator): -Febrile neutropenia (absolute neutrophil count \<1000/microliter \[μL\] and temperature ≥38.5°Celcius). -Grade 4 neutropenia for \>5 days. -Grade 4 thrombocytopenia with or without bleeding. -Grade 3 thrombocytopenia with bleeding. -Grade 4 anemia, unexplained by underlying disease. -Grade 3 or greater nausea, vomiting, or diarrhea if persistent despite optimal antiemetic or anti-diarrheal therapy. -Grade 3 or greater increase in transaminases lasting \>5 days. -Grade 3 or greater fatigue persisting \>7 days in absence of any other underlying cause. -Any other Grade 3 or greater non-hematologic toxicity (except fatigue as noted above) considered clinically significant by Investigator. -Toxicity of any grade resulting in dose delay of \>7 days. -Toxicity resulting in study drug discontinuation prior to completion of Cycle 1.
Outcome measures
| Measure |
Phase 2a: Cerdulatinib (PTCL Cohort) With AITL/TFH
n=3 Participants
Participants with PTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. This cohort included participants with cancer type of PTCL angioimmunoblastic T-cell lymphoma (AITCL/AITL) and PTCL with T-follicular helper phenotype (TFH).
|
Phase 1: Cerdulatinib 15 mg QD
n=3 Participants
Participants received oral cerdulatinib at 15 mg QD starting on Day 1 in 21-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 30 mg QD
n=6 Participants
Participants received oral cerdulatinib at 30 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 45 mg QD
n=7 Participants
Participants received oral cerdulatinib at 45 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 15 mg BID
n=3 Participants
Participants received oral cerdulatinib at 15 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 20 mg BID
n=3 Participants
Participants received oral cerdulatinib at 20 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 50 mg QD
n=4 Participants
Participants received oral cerdulatinib at 50 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 65 mg QD
n=6 Participants
Participants received oral cerdulatinib at 65 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 100 mg QD
n=3 Participants
Participants received oral cerdulatinib at 100 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 45 mg BID
n=5 Participants
Participants received oral cerdulatinib at 45 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 2a: Cerdulatinib (FL Cohort)
Participants with FL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
Phase 2a: Cerdulatinib (MZL/WM Cohort)
Participants with MZL/WM received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
Phase 2a: Cerdulatinib Plus Rituximab (FL Cohort)
Participants with FL received oral cerdulatinib at starting doses of 30 or 20 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval. Participants also received IV injections of rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, and 10.
|
Phase 2a: Cerdulatinib (aNHL Cohort)
Participants with aNHL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
Phase 2a: Cerdulatinib (CLL/SLL Cohort)
Participants with CLL/SLL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
Phase 2a: Cerdulatinib (PTCL Cohort)
Participants with PTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
Phase 2a: Cerdulatinib (CTCL Cohort)
Participants with CTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Number of Participants With a Dose Limiting Toxicity (DLT)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to End of Treatment (up to last day of Cycle 10 [cycle = 28 days])Population: The Efficacy Analysis Population included all participants who took at least 1 dose of study drug and had at least 1 post-baseline Investigator response assessment. Only the cohorts (arms) with participants with FL or with PTCL were applicable and evaluated for this Outcome Measure. Here, 'Number of participants analyzed' signifies participants evaluable for this outcome measure.
CR included: -Via a positron emission tomography (PET)/computed tomography (CT) scan, score of 1 (no uptake above background), 2 (uptake of \<mediastinum), or 3 (uptake of \>mediastinum but \<liver) for lymph nodes and extralymphatic sites; no new lesions; and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. -Via CT scan, target nodes/nodal masses regressed to \<1.5 centimeters (cm) in longest transverse diameter of a lesion (LDi); no extralymphatic sites of disease; organ enlargement has regressed to normal; and bone marrow was normal by morphology and if indeterminate, immunohistochemistry was negative. PR included: -Via a PET/CT scan, score of 4 (uptake of moderately \>liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with baseline and residual masses of any size. -Via CT scan, \>50% decrease in the sum of the product of perpendicular diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites.
Outcome measures
| Measure |
Phase 2a: Cerdulatinib (PTCL Cohort) With AITL/TFH
n=27 Participants
Participants with PTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. This cohort included participants with cancer type of PTCL angioimmunoblastic T-cell lymphoma (AITCL/AITL) and PTCL with T-follicular helper phenotype (TFH).
|
Phase 1: Cerdulatinib 15 mg QD
n=24 Participants
Participants received oral cerdulatinib at 15 mg QD starting on Day 1 in 21-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 30 mg QD
n=10 Participants
Participants received oral cerdulatinib at 30 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 45 mg QD
n=16 Participants
Participants received oral cerdulatinib at 45 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 15 mg BID
n=10 Participants
Participants received oral cerdulatinib at 15 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 20 mg BID
n=9 Participants
Participants received oral cerdulatinib at 20 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 50 mg QD
n=22 Participants
Participants received oral cerdulatinib at 50 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 65 mg QD
Participants received oral cerdulatinib at 65 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 100 mg QD
Participants received oral cerdulatinib at 100 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 45 mg BID
Participants received oral cerdulatinib at 45 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 2a: Cerdulatinib (FL Cohort)
Participants with FL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
Phase 2a: Cerdulatinib (MZL/WM Cohort)
Participants with MZL/WM received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
Phase 2a: Cerdulatinib Plus Rituximab (FL Cohort)
Participants with FL received oral cerdulatinib at starting doses of 30 or 20 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval. Participants also received IV injections of rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, and 10.
|
Phase 2a: Cerdulatinib (aNHL Cohort)
Participants with aNHL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
Phase 2a: Cerdulatinib (CLL/SLL Cohort)
Participants with CLL/SLL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
Phase 2a: Cerdulatinib (PTCL Cohort)
Participants with PTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
Phase 2a: Cerdulatinib (CTCL Cohort)
Participants with CTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2a: Number of Participants Achieving Overall Response Rate (Partial Response [PR] Plus Complete Response [CR]) as Assessed by the Investigator
|
14 Participants
|
12 Participants
|
6 Participants
|
15 Participants
|
5 Participants
|
0 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to End of Treatment (up to last day of Cycle 10 [cycle = 21 days or 28 days])Population: The Safety Analysis Population included participants who received at least 1 dose of study drug. Only data from participants in Phase 1 cohorts (arms) were applicable and evaluated for this Outcome Measure.
CR included: -Via a PET/CT scan, score of 1 (no uptake above background), 2 (uptake of \<mediastinum), or 3 (uptake of \>mediastinum but \<liver) for lymph nodes and extralymphatic sites; no new lesions; and no evidence of FDG-avid disease in bone marrow. -Via CT scan, target nodes/nodal masses regressed to \<1.5 cm in LDi; no extralymphatic sites of disease; organ enlargement has regressed to normal; and bone marrow was normal by morphology and if indeterminate, immunohistochemistry was negative. PR included: -Via a PET/CT scan, a score of 4 (uptake of moderately \>liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with baseline and residual masses of any size. -Via CT scan, \>50% decrease in the sum of the product of perpendicular diameters for multiple lesion of up to 6 target measurable nodes and extranodal sites.
Outcome measures
| Measure |
Phase 2a: Cerdulatinib (PTCL Cohort) With AITL/TFH
n=3 Participants
Participants with PTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. This cohort included participants with cancer type of PTCL angioimmunoblastic T-cell lymphoma (AITCL/AITL) and PTCL with T-follicular helper phenotype (TFH).
|
Phase 1: Cerdulatinib 15 mg QD
n=3 Participants
Participants received oral cerdulatinib at 15 mg QD starting on Day 1 in 21-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 30 mg QD
n=6 Participants
Participants received oral cerdulatinib at 30 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 45 mg QD
n=7 Participants
Participants received oral cerdulatinib at 45 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 15 mg BID
n=3 Participants
Participants received oral cerdulatinib at 15 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 20 mg BID
n=3 Participants
Participants received oral cerdulatinib at 20 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 50 mg QD
n=4 Participants
Participants received oral cerdulatinib at 50 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 65 mg QD
n=6 Participants
Participants received oral cerdulatinib at 65 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 100 mg QD
n=3 Participants
Participants received oral cerdulatinib at 100 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 45 mg BID
n=5 Participants
Participants received oral cerdulatinib at 45 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 2a: Cerdulatinib (FL Cohort)
Participants with FL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
Phase 2a: Cerdulatinib (MZL/WM Cohort)
Participants with MZL/WM received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
Phase 2a: Cerdulatinib Plus Rituximab (FL Cohort)
Participants with FL received oral cerdulatinib at starting doses of 30 or 20 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval. Participants also received IV injections of rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, and 10.
|
Phase 2a: Cerdulatinib (aNHL Cohort)
Participants with aNHL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
Phase 2a: Cerdulatinib (CLL/SLL Cohort)
Participants with CLL/SLL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
Phase 2a: Cerdulatinib (PTCL Cohort)
Participants with PTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
Phase 2a: Cerdulatinib (CTCL Cohort)
Participants with CTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Number of Participants Achieving Overall Response Rate (Partial Response [PR] Plus Complete Response [CR]) as Assessed by the Investigator
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to End of Treatment (up to last day of Cycle 10 [cycle = 21 days or 28 days])Population: The Safety Analysis Population included participants who received at least 1 dose of study drug. Only data from participants in Phase 1 cohorts (arms) were applicable and evaluated for this Outcome Measure.
Clinical benefit was defined as achieving stable disease (SD) or better, as assessed by the Investigator. SD included: -Via a PET/CT scan, a score of 4 (uptake of moderately \>liver) or 5 (uptake markedly higher than liver and/or new lesions) with no significant change in FDG uptake from baseline at interim or end of treatment; no new lesions; and no change from baseline in bone marrow. -Via CT scan, \<50% decrease from baseline in sum of products of the greatest perpendicular diameters (SPD) of up to 6 dominant, measurable nodes and extranodal sites; no increase consistent with progression in nonmeasured lesions or organ enlargement; and no new lesions.
Outcome measures
| Measure |
Phase 2a: Cerdulatinib (PTCL Cohort) With AITL/TFH
n=3 Participants
Participants with PTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. This cohort included participants with cancer type of PTCL angioimmunoblastic T-cell lymphoma (AITCL/AITL) and PTCL with T-follicular helper phenotype (TFH).
|
Phase 1: Cerdulatinib 15 mg QD
n=3 Participants
Participants received oral cerdulatinib at 15 mg QD starting on Day 1 in 21-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 30 mg QD
n=6 Participants
Participants received oral cerdulatinib at 30 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 45 mg QD
n=7 Participants
Participants received oral cerdulatinib at 45 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 15 mg BID
n=3 Participants
Participants received oral cerdulatinib at 15 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 20 mg BID
n=3 Participants
Participants received oral cerdulatinib at 20 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 50 mg QD
n=4 Participants
Participants received oral cerdulatinib at 50 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 65 mg QD
n=6 Participants
Participants received oral cerdulatinib at 65 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 100 mg QD
n=3 Participants
Participants received oral cerdulatinib at 100 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 45 mg BID
n=5 Participants
Participants received oral cerdulatinib at 45 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 2a: Cerdulatinib (FL Cohort)
Participants with FL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
Phase 2a: Cerdulatinib (MZL/WM Cohort)
Participants with MZL/WM received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
Phase 2a: Cerdulatinib Plus Rituximab (FL Cohort)
Participants with FL received oral cerdulatinib at starting doses of 30 or 20 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval. Participants also received IV injections of rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, and 10.
|
Phase 2a: Cerdulatinib (aNHL Cohort)
Participants with aNHL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
Phase 2a: Cerdulatinib (CLL/SLL Cohort)
Participants with CLL/SLL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
Phase 2a: Cerdulatinib (PTCL Cohort)
Participants with PTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
Phase 2a: Cerdulatinib (CTCL Cohort)
Participants with CTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Number of Participants Achieving Clinical Benefit
|
1 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])Population: The Safety Analysis Population included participants who received at least 1 dose of study drug.
An AE is any untoward medical occurrence, which may or may not have a causal relationship to the study drug, including: unfavorable and unintended sign, symptom, or disease temporally associated with the use of the study drug; any newly occurring event or exacerbation of previous condition (for example, increase in severity or frequency) since the administration of study drug; recurrence of an intermittent medical condition not present at baseline; any deterioration in a laboratory value or other clinical test that is associated with symptoms or leads to a change in study treatment or concomitant treatment or discontinuation from study drug; and AEs related to a study intervention. An SAE is an AE that is fatal, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or a congenital anomaly/birth defect.
Outcome measures
| Measure |
Phase 2a: Cerdulatinib (PTCL Cohort) With AITL/TFH
n=3 Participants
Participants with PTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. This cohort included participants with cancer type of PTCL angioimmunoblastic T-cell lymphoma (AITCL/AITL) and PTCL with T-follicular helper phenotype (TFH).
|
Phase 1: Cerdulatinib 15 mg QD
n=3 Participants
Participants received oral cerdulatinib at 15 mg QD starting on Day 1 in 21-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 30 mg QD
n=6 Participants
Participants received oral cerdulatinib at 30 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 45 mg QD
n=7 Participants
Participants received oral cerdulatinib at 45 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 15 mg BID
n=3 Participants
Participants received oral cerdulatinib at 15 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 20 mg BID
n=3 Participants
Participants received oral cerdulatinib at 20 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 50 mg QD
n=4 Participants
Participants received oral cerdulatinib at 50 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 65 mg QD
n=6 Participants
Participants received oral cerdulatinib at 65 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 100 mg QD
n=3 Participants
Participants received oral cerdulatinib at 100 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 45 mg BID
n=5 Participants
Participants received oral cerdulatinib at 45 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 2a: Cerdulatinib (FL Cohort)
n=42 Participants
Participants with FL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
Phase 2a: Cerdulatinib (MZL/WM Cohort)
n=12 Participants
Participants with MZL/WM received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
Phase 2a: Cerdulatinib Plus Rituximab (FL Cohort)
n=26 Participants
Participants with FL received oral cerdulatinib at starting doses of 30 or 20 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval. Participants also received IV injections of rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, and 10.
|
Phase 2a: Cerdulatinib (aNHL Cohort)
n=6 Participants
Participants with aNHL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
Phase 2a: Cerdulatinib (CLL/SLL Cohort)
n=28 Participants
Participants with CLL/SLL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
Phase 2a: Cerdulatinib (PTCL Cohort)
n=65 Participants
Participants with PTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
Phase 2a: Cerdulatinib (CTCL Cohort)
n=41 Participants
Participants with CTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 and Phase 2: Number of Participants With an Adverse Event (AE) or a Serious Adverse Event (SAE)
AE
|
3 Participants
|
3 Participants
|
6 Participants
|
7 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
6 Participants
|
3 Participants
|
5 Participants
|
42 Participants
|
12 Participants
|
26 Participants
|
6 Participants
|
28 Participants
|
65 Participants
|
41 Participants
|
|
Phase 1 and Phase 2: Number of Participants With an Adverse Event (AE) or a Serious Adverse Event (SAE)
SAE
|
1 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
22 Participants
|
2 Participants
|
7 Participants
|
3 Participants
|
17 Participants
|
42 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Cycle (C)1 Day (D)1: predose (0), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, and 72 hours postdose (except 15mg QD); C1D1: 0, 0.5, 1, 2, 3, 4, 6, 8, and 12 hours postdose (15mg QD); C2D1: 0, 0.5, 1, 2, 3, 4, 6, 8, and 12 hours postdose (all doses)Population: The Pharmacokinetic Analysis Population consisted of all participants who received the requisite treatments and have data at the required timepoints. Only data from participants in Phase 1 cohorts (arms) were applicable and evaluated for this Outcome Measure. Here, 'Number of participants analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable at specified timepoints.
Outcome measures
| Measure |
Phase 2a: Cerdulatinib (PTCL Cohort) With AITL/TFH
n=3 Participants
Participants with PTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. This cohort included participants with cancer type of PTCL angioimmunoblastic T-cell lymphoma (AITCL/AITL) and PTCL with T-follicular helper phenotype (TFH).
|
Phase 1: Cerdulatinib 15 mg QD
n=3 Participants
Participants received oral cerdulatinib at 15 mg QD starting on Day 1 in 21-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 30 mg QD
n=6 Participants
Participants received oral cerdulatinib at 30 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 45 mg QD
n=7 Participants
Participants received oral cerdulatinib at 45 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 15 mg BID
n=3 Participants
Participants received oral cerdulatinib at 15 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 20 mg BID
n=3 Participants
Participants received oral cerdulatinib at 20 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 50 mg QD
n=4 Participants
Participants received oral cerdulatinib at 50 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 65 mg QD
n=5 Participants
Participants received oral cerdulatinib at 65 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 100 mg QD
n=3 Participants
Participants received oral cerdulatinib at 100 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 45 mg BID
n=5 Participants
Participants received oral cerdulatinib at 45 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 2a: Cerdulatinib (FL Cohort)
Participants with FL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
Phase 2a: Cerdulatinib (MZL/WM Cohort)
Participants with MZL/WM received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
Phase 2a: Cerdulatinib Plus Rituximab (FL Cohort)
Participants with FL received oral cerdulatinib at starting doses of 30 or 20 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval. Participants also received IV injections of rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, and 10.
|
Phase 2a: Cerdulatinib (aNHL Cohort)
Participants with aNHL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
Phase 2a: Cerdulatinib (CLL/SLL Cohort)
Participants with CLL/SLL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
Phase 2a: Cerdulatinib (PTCL Cohort)
Participants with PTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
Phase 2a: Cerdulatinib (CTCL Cohort)
Participants with CTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Area Under the Plasma Concentration-Time Curve From 0 to 12 Hours (AUC0-12) of Cerdulatinib
Day 1 of Cycle 1
|
2064 hours*nanograms/milliliter (h*ng/mL)
Standard Deviation 666.52
|
709.6 hours*nanograms/milliliter (h*ng/mL)
Standard Deviation 37.823
|
1040 hours*nanograms/milliliter (h*ng/mL)
Standard Deviation 347.34
|
1826 hours*nanograms/milliliter (h*ng/mL)
Standard Deviation 713.67
|
601.4 hours*nanograms/milliliter (h*ng/mL)
Standard Deviation 118.04
|
674.5 hours*nanograms/milliliter (h*ng/mL)
Standard Deviation 113.34
|
2465 hours*nanograms/milliliter (h*ng/mL)
Standard Deviation 305.70
|
2719 hours*nanograms/milliliter (h*ng/mL)
Standard Deviation 1208.2
|
2758 hours*nanograms/milliliter (h*ng/mL)
Standard Deviation 969.37
|
1335 hours*nanograms/milliliter (h*ng/mL)
Standard Deviation 530.56
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1: Area Under the Plasma Concentration-Time Curve From 0 to 12 Hours (AUC0-12) of Cerdulatinib
Day 1 of Cycle 2
|
6313 hours*nanograms/milliliter (h*ng/mL)
Standard Deviation 166.81
|
1321 hours*nanograms/milliliter (h*ng/mL)
Standard Deviation 140.21
|
1900 hours*nanograms/milliliter (h*ng/mL)
Standard Deviation 918.79
|
6804 hours*nanograms/milliliter (h*ng/mL)
Standard Deviation 3065.6
|
2129 hours*nanograms/milliliter (h*ng/mL)
Standard Deviation 533.14
|
2779 hours*nanograms/milliliter (h*ng/mL)
Standard Deviation 458.94
|
5871 hours*nanograms/milliliter (h*ng/mL)
Standard Deviation 3685.1
|
6215 hours*nanograms/milliliter (h*ng/mL)
Standard Deviation 249.64
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to End of Treatment (up to last day of Cycle 10 [cycle = 28 days])Population: The Efficacy Analysis Population included all participants who took at least 1 dose of study drug and had at least 1 post-baseline Investigator response assessment. Only the cohorts (arms) with participants with FL or with PTCL were applicable and evaluated for this Outcome Measure. Here, 'Number of participants analyzed' signifies participants evaluable for this outcome measure.
PFS=(first documentation of disease progression \[DP\] or death \[whichever occurred first\]-study drug first dose date+1)/30.4375 in months. PFS right censored for 1 of these conditions: 1) no baseline disease assessments; 2) starting new anticancer therapy before documented DP/death; 3) DP/death immediately after \>6 months since last disease assessment (or \>12 months if after last cycle); \& alive without documented DP. 95% confidence interval estimated using Brookmeyer method. DP included: -Via a PET/CT scan, score of 4 (uptake of moderately \>liver) or 5 (uptake markedly higher than liver and/or new lesions) with uptake increase in intensity, new FDG-avid foci, \& no nonmeasured lesions. -Via CT, abnormal individual node/lesion with significant LDi or shortest axis perpendicular to LDi increase; prior splenomegaly, \>50% splenic length increase; if no prior splenomegaly, ≥2 cm splenic length increase; new or recurrent splenomegaly; new/clear progression of preexisting nonmeasured lesions.
Outcome measures
| Measure |
Phase 2a: Cerdulatinib (PTCL Cohort) With AITL/TFH
n=27 Participants
Participants with PTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. This cohort included participants with cancer type of PTCL angioimmunoblastic T-cell lymphoma (AITCL/AITL) and PTCL with T-follicular helper phenotype (TFH).
|
Phase 1: Cerdulatinib 15 mg QD
n=24 Participants
Participants received oral cerdulatinib at 15 mg QD starting on Day 1 in 21-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 30 mg QD
n=10 Participants
Participants received oral cerdulatinib at 30 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 45 mg QD
n=16 Participants
Participants received oral cerdulatinib at 45 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 15 mg BID
n=10 Participants
Participants received oral cerdulatinib at 15 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 20 mg BID
n=9 Participants
Participants received oral cerdulatinib at 20 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 50 mg QD
n=22 Participants
Participants received oral cerdulatinib at 50 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 65 mg QD
Participants received oral cerdulatinib at 65 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 100 mg QD
Participants received oral cerdulatinib at 100 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 45 mg BID
Participants received oral cerdulatinib at 45 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 2a: Cerdulatinib (FL Cohort)
Participants with FL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
Phase 2a: Cerdulatinib (MZL/WM Cohort)
Participants with MZL/WM received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
Phase 2a: Cerdulatinib Plus Rituximab (FL Cohort)
Participants with FL received oral cerdulatinib at starting doses of 30 or 20 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval. Participants also received IV injections of rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, and 10.
|
Phase 2a: Cerdulatinib (aNHL Cohort)
Participants with aNHL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
Phase 2a: Cerdulatinib (CLL/SLL Cohort)
Participants with CLL/SLL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
Phase 2a: Cerdulatinib (PTCL Cohort)
Participants with PTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
Phase 2a: Cerdulatinib (CTCL Cohort)
Participants with CTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2a: Median Time to Progression-Free Survival (PFS)
|
4.57 months
Interval 1.71 to 9.99
|
12.68 months
Interval 4.53 to
NA=not applicable. Due to several participants who were censored (see conditions detailed above) the upper limit could not be estimated.
|
3.61 months
Interval 1.28 to
Due to several participants who were censored (see conditions detailed above) the upper limit could not be estimated.
|
18.33 months
Interval 10.74 to
Due to several participants who were censored (see conditions detailed above) the upper limit could not be estimated.
|
NA months
Interval 3.58 to
Due to several participants who were censored (see conditions detailed above) the median and the upper limit could not be estimated.
|
1.18 months
Interval 0.26 to 3.58
|
3.45 months
Interval 2.07 to 5.62
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to End of Treatment (up to last day of Cycle 10 [cycle = 28 days])Population: The Efficacy Analysis Population included all participants who took at least 1 dose of study drug and had at least 1 post-baseline Investigator response assessment. Only the cohorts (arms) with participants with FL or with PTCL were applicable and evaluated for this Outcome Measure. Here, 'Number of participants analyzed' signifies participants evaluable for this outcome measure.
Clinical benefit was defined as achieving SD or better, as assessed by the Investigator. SD included: -Via a PET/CT scan, a score of 4 (uptake of moderately \>liver) or 5 (uptake markedly higher than liver and/or new lesions) with no significant change in FDG uptake from baseline at interim or end of treatment; no new lesions; and no change from baseline in bone marrow. -Via CT scan, \<50% decrease from baseline in sum of products of the greatest perpendicular diameters (SPD) of up to 6 dominant, measurable nodes and extranodal sites; no increase consistent with progression in nonmeasured lesions or organ enlargement; and no new lesions.
Outcome measures
| Measure |
Phase 2a: Cerdulatinib (PTCL Cohort) With AITL/TFH
n=27 Participants
Participants with PTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. This cohort included participants with cancer type of PTCL angioimmunoblastic T-cell lymphoma (AITCL/AITL) and PTCL with T-follicular helper phenotype (TFH).
|
Phase 1: Cerdulatinib 15 mg QD
n=24 Participants
Participants received oral cerdulatinib at 15 mg QD starting on Day 1 in 21-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 30 mg QD
n=10 Participants
Participants received oral cerdulatinib at 30 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 45 mg QD
n=16 Participants
Participants received oral cerdulatinib at 45 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 15 mg BID
n=10 Participants
Participants received oral cerdulatinib at 15 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 20 mg BID
n=9 Participants
Participants received oral cerdulatinib at 20 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 50 mg QD
n=22 Participants
Participants received oral cerdulatinib at 50 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 65 mg QD
Participants received oral cerdulatinib at 65 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 100 mg QD
Participants received oral cerdulatinib at 100 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 45 mg BID
Participants received oral cerdulatinib at 45 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 2a: Cerdulatinib (FL Cohort)
Participants with FL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
Phase 2a: Cerdulatinib (MZL/WM Cohort)
Participants with MZL/WM received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
Phase 2a: Cerdulatinib Plus Rituximab (FL Cohort)
Participants with FL received oral cerdulatinib at starting doses of 30 or 20 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval. Participants also received IV injections of rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, and 10.
|
Phase 2a: Cerdulatinib (aNHL Cohort)
Participants with aNHL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
Phase 2a: Cerdulatinib (CLL/SLL Cohort)
Participants with CLL/SLL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
Phase 2a: Cerdulatinib (PTCL Cohort)
Participants with PTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
Phase 2a: Cerdulatinib (CTCL Cohort)
Participants with CTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2a: Number of Participants Achieving Clinical Benefit
|
17 Participants
|
19 Participants
|
8 Participants
|
16 Participants
|
10 Participants
|
2 Participants
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to End of Treatment (up to last day of Cycle 10 [cycle = 28 days])Population: The Efficacy Analysis Population included all participants who took at least 1 dose of study drug and had at least 1 post-baseline Investigator response assessment. Only the cohorts (arms) with participants with FL or with PTCL were applicable and evaluated for this Outcome Measure. Here, 'Number of participants analyzed' signifies participants evaluable for this outcome measure.
DMR was defined as achieving a ≥50% decrease from baseline in the SPD of the target nodal and extranodal lesions. SPD at a visit was considered missing if any target lesion was not evaluated.
Outcome measures
| Measure |
Phase 2a: Cerdulatinib (PTCL Cohort) With AITL/TFH
n=27 Participants
Participants with PTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. This cohort included participants with cancer type of PTCL angioimmunoblastic T-cell lymphoma (AITCL/AITL) and PTCL with T-follicular helper phenotype (TFH).
|
Phase 1: Cerdulatinib 15 mg QD
n=24 Participants
Participants received oral cerdulatinib at 15 mg QD starting on Day 1 in 21-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 30 mg QD
n=10 Participants
Participants received oral cerdulatinib at 30 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 45 mg QD
n=16 Participants
Participants received oral cerdulatinib at 45 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 15 mg BID
n=10 Participants
Participants received oral cerdulatinib at 15 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 20 mg BID
n=9 Participants
Participants received oral cerdulatinib at 20 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 50 mg QD
n=22 Participants
Participants received oral cerdulatinib at 50 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 65 mg QD
Participants received oral cerdulatinib at 65 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 100 mg QD
Participants received oral cerdulatinib at 100 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 45 mg BID
Participants received oral cerdulatinib at 45 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 2a: Cerdulatinib (FL Cohort)
Participants with FL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
Phase 2a: Cerdulatinib (MZL/WM Cohort)
Participants with MZL/WM received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
Phase 2a: Cerdulatinib Plus Rituximab (FL Cohort)
Participants with FL received oral cerdulatinib at starting doses of 30 or 20 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval. Participants also received IV injections of rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, and 10.
|
Phase 2a: Cerdulatinib (aNHL Cohort)
Participants with aNHL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
Phase 2a: Cerdulatinib (CLL/SLL Cohort)
Participants with CLL/SLL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
Phase 2a: Cerdulatinib (PTCL Cohort)
Participants with PTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
Phase 2a: Cerdulatinib (CTCL Cohort)
Participants with CTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2a: Number of Participants Achieving Dominant Mass Response (DMR)
|
15 Participants
|
14 Participants
|
5 Participants
|
14 Participants
|
7 Participants
|
1 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Phase 1: Cerdulatinib 15 mg QD
Phase 1: Cerdulatinib 30 mg QD
Phase 1: Cerdulatinib 45 mg QD
Phase 1: Cerdulatinib 15 mg BID
Phase 1: Cerdulatinib 40 mg QD
Phase 1: Cerdulatinib 20 mg BID
Phase 1: Cerdulatinib 50 mg QD
Phase 1: Cerdulatinib 65 mg QD
Phase 1: Cerdulatinib 100 mg QD
Phase 1: Cerdulatinib 45 mg BID
Phase 2a: Cerdulatinib (FL Cohort)
Phase 2a: Cerdulatinib (MZL/WM Cohort)
Phase 2a: Cerdulatinib Plus Rituximab (FL Cohort)
Phase 2a: Cerdulatinib (aNHL Cohort)
Phase 2a: Cerdulatinib (CLL/SLL Cohort)
Phase 2a: Cerdulatinib (PTCL Cohort)
Phase 2a: Cerdulatinib (CTCL Cohort)
Serious adverse events
| Measure |
Phase 1: Cerdulatinib 15 mg QD
n=3 participants at risk
Participants received oral cerdulatinib at 15 mg QD starting on Day 1 in 21-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 30 mg QD
n=6 participants at risk
Participants received oral cerdulatinib at 30 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 45 mg QD
n=7 participants at risk
Participants received oral cerdulatinib at 45 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 15 mg BID
n=3 participants at risk
Participants received oral cerdulatinib at 15 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 40 mg QD
n=3 participants at risk
Participants received oral cerdulatinib at 40 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 20 mg BID
n=3 participants at risk
Participants received oral cerdulatinib at 20 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 50 mg QD
n=4 participants at risk
Participants received oral cerdulatinib at 50 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 65 mg QD
n=6 participants at risk
Participants received oral cerdulatinib at 65 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 100 mg QD
n=3 participants at risk
Participants received oral cerdulatinib at 100 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 45 mg BID
n=5 participants at risk
Participants received oral cerdulatinib at 45 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 2a: Cerdulatinib (FL Cohort)
n=42 participants at risk
Participants with FL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
|
Phase 2a: Cerdulatinib (MZL/WM Cohort)
n=12 participants at risk
Participants with MZL/WM received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
|
Phase 2a: Cerdulatinib Plus Rituximab (FL Cohort)
n=26 participants at risk
Participants with FL received oral cerdulatinib at starting doses of 30 or 20 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. Participants also received IV injections of rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, and 10.
|
Phase 2a: Cerdulatinib (aNHL Cohort)
n=6 participants at risk
Participants with aNHL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
|
Phase 2a: Cerdulatinib (CLL/SLL Cohort)
n=28 participants at risk
Participants with CLL/SLL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
|
Phase 2a: Cerdulatinib (PTCL Cohort)
n=65 participants at risk
Participants with PTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
|
Phase 2a: Cerdulatinib (CTCL Cohort)
n=41 participants at risk
Participants with CTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
T-cell lymphoma
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.8%
1/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
4.8%
2/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.8%
1/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
4.6%
3/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
4.9%
2/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.1%
2/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
4.8%
2/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.1%
2/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Hepatic infection
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
7.1%
3/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
19.2%
5/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
14.3%
4/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
4.6%
3/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
4.9%
2/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.1%
2/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.8%
1/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.1%
2/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
General disorders
Disease progression
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
7.7%
5/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin lymphoma
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.8%
1/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
9.2%
6/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
4.9%
2/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Nocardiosis
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
7.1%
3/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.1%
2/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.8%
1/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Epstein-Barr virus infection reactivation
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.1%
2/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Septic shock
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
4.9%
2/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Brain abscess
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Corynebacterium sepsis
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cytomegalovirus gastritis
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cytomegalovirus viraemia
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Device related infection
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Localised infection
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pseudomonal sepsis
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Scedosporium infection
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Infections and infestations
West Nile viral infection
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Wound infection
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.8%
1/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Fistula of small intestine
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Uvulitis
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
20.0%
13/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
4.9%
2/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.1%
2/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma metastatic
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal squamous cell carcinoma
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
General disorders
Death
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
General disorders
Sudden death
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
General disorders
Swelling face
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Methaemoglobinaemia
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.8%
1/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
7.1%
3/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
4.8%
2/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
7.3%
3/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Embolism
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.1%
2/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Acute motor axonal neuropathy
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.8%
1/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.1%
2/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.8%
1/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.8%
1/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Investigations
Amylase increased
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.8%
1/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Graft versus host disease
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Drug reaction with eosinophilia and systemic symptoms
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Infection
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Phase 1: Cerdulatinib 15 mg QD
n=3 participants at risk
Participants received oral cerdulatinib at 15 mg QD starting on Day 1 in 21-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 30 mg QD
n=6 participants at risk
Participants received oral cerdulatinib at 30 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 45 mg QD
n=7 participants at risk
Participants received oral cerdulatinib at 45 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 15 mg BID
n=3 participants at risk
Participants received oral cerdulatinib at 15 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 40 mg QD
n=3 participants at risk
Participants received oral cerdulatinib at 40 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 20 mg BID
n=3 participants at risk
Participants received oral cerdulatinib at 20 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 50 mg QD
n=4 participants at risk
Participants received oral cerdulatinib at 50 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 65 mg QD
n=6 participants at risk
Participants received oral cerdulatinib at 65 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 100 mg QD
n=3 participants at risk
Participants received oral cerdulatinib at 100 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 1: Cerdulatinib 45 mg BID
n=5 participants at risk
Participants received oral cerdulatinib at 45 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
|
Phase 2a: Cerdulatinib (FL Cohort)
n=42 participants at risk
Participants with FL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
|
Phase 2a: Cerdulatinib (MZL/WM Cohort)
n=12 participants at risk
Participants with MZL/WM received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
|
Phase 2a: Cerdulatinib Plus Rituximab (FL Cohort)
n=26 participants at risk
Participants with FL received oral cerdulatinib at starting doses of 30 or 20 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. Participants also received IV injections of rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, and 10.
|
Phase 2a: Cerdulatinib (aNHL Cohort)
n=6 participants at risk
Participants with aNHL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
|
Phase 2a: Cerdulatinib (CLL/SLL Cohort)
n=28 participants at risk
Participants with CLL/SLL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
|
Phase 2a: Cerdulatinib (PTCL Cohort)
n=65 participants at risk
Participants with PTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
|
Phase 2a: Cerdulatinib (CTCL Cohort)
n=41 participants at risk
Participants with CTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
7.1%
3/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
15.4%
4/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
4.9%
2/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Investigations
Lipase Increased
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
33.3%
14/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
25.0%
3/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
38.5%
10/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
28.6%
8/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
29.2%
19/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
58.5%
24/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Investigations
Amylase Increased
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
31.0%
13/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
2/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
26.9%
7/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
21.4%
6/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
43.1%
28/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
51.2%
21/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
7.1%
3/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
15.4%
4/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
7.7%
5/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
17.1%
7/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
7.1%
3/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
7.7%
2/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
15.4%
10/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
12.2%
5/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
4.8%
2/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
7.7%
2/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
14.3%
4/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
7.7%
5/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
42.9%
3/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
66.7%
2/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
66.7%
2/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
50.0%
2/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
66.7%
4/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
100.0%
3/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
100.0%
5/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
54.8%
23/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
41.7%
5/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
80.8%
21/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
33.3%
2/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
71.4%
20/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
41.5%
27/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
48.8%
20/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
42.9%
3/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
66.7%
2/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
66.7%
2/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
33.3%
2/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
40.0%
2/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
54.8%
23/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
50.0%
6/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
50.0%
13/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
50.0%
3/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
50.0%
14/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
32.3%
21/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
41.5%
17/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal Pain
|
33.3%
1/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
28.6%
2/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
50.0%
3/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
66.7%
2/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
31.0%
13/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
2/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
26.9%
7/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
21.4%
6/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
24.6%
16/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
7.3%
3/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
2/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
28.6%
2/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
23.8%
10/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
2/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
30.8%
8/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
33.3%
2/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
6.2%
4/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
14.6%
6/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
21.4%
9/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
2/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
23.1%
6/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
50.0%
3/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
21.4%
6/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
9.2%
6/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
12.2%
5/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
28.6%
2/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
9.5%
4/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
11.5%
3/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
6.2%
4/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
4.9%
2/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
33.3%
2/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
85.7%
6/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
50.0%
2/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
83.3%
5/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
60.0%
3/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
50.0%
21/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
58.3%
7/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
57.7%
15/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
33.3%
2/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
57.1%
16/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
27.7%
18/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
34.1%
14/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
33.3%
2/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
57.1%
4/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
66.7%
2/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
28.6%
12/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
19.2%
5/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
21.4%
6/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
12.3%
8/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
9.8%
4/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
33.3%
1/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
42.9%
3/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
66.7%
2/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
66.7%
2/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
7/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
19.2%
5/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
33.3%
2/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
39.3%
11/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
12.3%
8/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
7.3%
3/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
7.1%
3/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.8%
1/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
6.2%
4/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
4.9%
2/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
33.3%
1/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
42.9%
3/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
66.7%
2/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
7/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
2/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
15.4%
4/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
32.1%
9/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
9.2%
6/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
14.6%
6/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
33.3%
1/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
33.3%
2/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
28.6%
2/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
28.6%
2/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
21.4%
9/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
15.4%
4/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
17.9%
5/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
12.3%
8/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
40.0%
2/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
7/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
7.7%
2/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
14.3%
4/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
10.8%
7/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
4.9%
2/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
33.3%
1/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Investigations
Weight Decreased
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
40.0%
2/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
4.8%
2/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
19.2%
5/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
32.1%
9/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
6.2%
4/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Investigations
Neutrophil Count Decreased
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
11.9%
5/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
7.7%
2/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
10.7%
3/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
15.4%
10/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
28.6%
2/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
50.0%
2/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
9.5%
4/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
33.3%
4/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
23.1%
6/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
33.3%
2/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
32.1%
9/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
32.3%
21/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
29.3%
12/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
33.3%
2/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
21.4%
9/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
2/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
30.8%
8/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
14.3%
4/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
20.0%
13/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
14.6%
6/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
28.6%
2/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.8%
1/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
10.7%
3/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.1%
2/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
7.3%
3/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
28.6%
2/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
26.2%
11/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
2/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
15.4%
4/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
25.0%
7/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
18.5%
12/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
7.3%
3/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
33.3%
1/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
11.9%
5/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
26.2%
11/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
7.7%
2/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
14.3%
4/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
12.3%
8/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
14.6%
6/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
33.3%
1/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
7/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
11.5%
3/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.1%
2/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
7.3%
3/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
14.3%
6/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
11.5%
3/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
14.3%
4/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
10.8%
7/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
4.9%
2/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
20.0%
1/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
7.7%
2/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
10.7%
3/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
6.2%
4/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
4.9%
2/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
19.0%
8/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
19.2%
5/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
12.3%
8/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
7.3%
3/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
7/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
2/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
15.4%
4/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
10.7%
3/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.1%
2/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
2/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
7.7%
2/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
10.7%
3/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
7.3%
3/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
General disorders
Oedema Peripheral
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
7/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
7.7%
2/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
10.7%
3/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
6.2%
4/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
9.8%
4/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
General disorders
Chills
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
9.5%
4/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
25.0%
3/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
11.5%
3/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
14.3%
4/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
1.5%
1/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
14.3%
6/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.8%
1/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
6.2%
4/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
4.9%
2/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
2/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
7.7%
2/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
14.3%
4/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
10.8%
7/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
4.9%
2/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
7.1%
3/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
7.7%
2/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
6.2%
4/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
9.8%
4/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
11.5%
3/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
17.1%
7/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
7.1%
3/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
6.2%
4/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
7.1%
3/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
11.5%
3/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
4.6%
3/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
9.8%
4/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
2/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
7.7%
5/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
9.8%
4/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
11.9%
5/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
11.5%
3/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
14.3%
4/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
4.6%
3/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
2.4%
1/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
9.5%
4/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
10.7%
3/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
4.6%
3/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
12.2%
5/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
11.9%
5/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
2/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
15.4%
4/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
25.0%
7/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
20.0%
13/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
19.5%
8/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
19.0%
8/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
2/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
19.2%
5/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
28.6%
8/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
9.2%
6/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
7.3%
3/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
7.1%
3/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
7.7%
2/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
14.3%
4/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.1%
2/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
9.8%
4/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
11.9%
5/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
15.4%
4/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
14.3%
4/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
4.6%
3/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
12.2%
5/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Skin Infection
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
6.2%
4/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
12.2%
5/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
4.8%
2/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
7.7%
2/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
33.3%
2/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
14.3%
4/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
3.1%
2/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
4.9%
2/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/7 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/4 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
0.00%
0/5 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
23.8%
10/42 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
30.8%
8/26 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
14.3%
4/28 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
4.6%
3/65 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
7.3%
3/41 • Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
The Safety Analysis Population included participants who received at least 1 dose of study drug.
|
Additional Information
Alexion Pharmaceuticals, Inc.
Alexion Pharmaceuticals, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place