Trial Outcomes & Findings for Romidepsin, CC-486 (5-azacitidine), Dexamethasone, and Lenalidomide (RAdR) for Relapsed/Refractory T-cell Malignancies (NCT NCT04447027)
NCT ID: NCT04447027
Last Updated: 2026-01-30
Results Overview
The MTD is the dose level at which no more than 1 of up to 6 participants experience dose-limiting toxicity (DLT) during the DLT evaluation window(s), or the dose below that at which at least 2 (of ≤6) participants have DLT. A DLT is defined as any treatment-emergent and related severe (grade ≥3) toxicity related to lenalidomide, romidepsin and/or CC-486 (5-azacitidine) and occurring during the maximum tolerated dose (MTD) observation time, defined as day -7 until end of cycle 1 (normally day 22).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
26 participants
Primary outcome timeframe
21 days
Results posted on
2026-01-30
Participant Flow
Participant milestones
| Measure |
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide
T-cell Malignancies, Dose Escalation, Arm 1, Dose Level -1
Arm 1, Dose Level -1: Lenalidomide 2.5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 200 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
|
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide
T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 1
Arm 1, Dose Level 1: Lenalidomide 5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
|
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide
T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 2
Arm 1, Dose Level 2: Lenalidomide 10 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
|
Arm 1, Cohort 1, Dose Level 3 Dose Escalation
T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 3
Arm 1, Dose Level 3: Lenalidomide 15 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
|
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide
T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 4
Arm 1, Dose Level 4: Lenalidomide 20 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
|
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide
T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 2
Arm 2, Dose Level 2: Lenalidomide by oral intake at maximum tolerated dose (MTD) on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.
|
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide
T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 4
Arm 2, Dose Level 4: Lenalidomide by oral intake at maximum tolerated dose (MTD) Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.
|
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide
T-cell Malignancies, Dose Expansion, Arm 3, Dose Level 4
Arm 3, Dose Level 4: Lenalidomide 20 mg maximum tolerated dose (MTD) by oral intake at on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.
|
Dose Level -2 Lenalidomide
No participants were enrolled on this dose level. Dose Level-2: Lenalidomide 0 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 200 mg by mouth (PO Day) 1 to 10; Romidepsin 10 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10.
|
|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation
STARTED
|
2
|
6
|
6
|
3
|
3
|
0
|
0
|
0
|
0
|
|
Dose Escalation
COMPLETED
|
1
|
1
|
2
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Dose Escalation
NOT COMPLETED
|
1
|
5
|
4
|
3
|
1
|
0
|
0
|
0
|
0
|
|
Dose Expansion
STARTED
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
3
|
0
|
|
Dose Expansion
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
|
Dose Expansion
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide
T-cell Malignancies, Dose Escalation, Arm 1, Dose Level -1
Arm 1, Dose Level -1: Lenalidomide 2.5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 200 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
|
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide
T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 1
Arm 1, Dose Level 1: Lenalidomide 5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
|
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide
T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 2
Arm 1, Dose Level 2: Lenalidomide 10 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
|
Arm 1, Cohort 1, Dose Level 3 Dose Escalation
T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 3
Arm 1, Dose Level 3: Lenalidomide 15 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
|
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide
T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 4
Arm 1, Dose Level 4: Lenalidomide 20 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
|
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide
T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 2
Arm 2, Dose Level 2: Lenalidomide by oral intake at maximum tolerated dose (MTD) on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.
|
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide
T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 4
Arm 2, Dose Level 4: Lenalidomide by oral intake at maximum tolerated dose (MTD) Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.
|
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide
T-cell Malignancies, Dose Expansion, Arm 3, Dose Level 4
Arm 3, Dose Level 4: Lenalidomide 20 mg maximum tolerated dose (MTD) by oral intake at on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.
|
Dose Level -2 Lenalidomide
No participants were enrolled on this dose level. Dose Level-2: Lenalidomide 0 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 200 mg by mouth (PO Day) 1 to 10; Romidepsin 10 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10.
|
|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation
Withdrawal by Subject
|
1
|
4
|
3
|
3
|
1
|
0
|
0
|
0
|
0
|
|
Dose Escalation
Refused further treatment
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Expansion
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
2
|
0
|
Baseline Characteristics
Romidepsin, CC-486 (5-azacitidine), Dexamethasone, and Lenalidomide (RAdR) for Relapsed/Refractory T-cell Malignancies
Baseline characteristics by cohort
| Measure |
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide
n=2 Participants
T-cell Malignancies, Dose Escalation, Arm 1, Dose Level -1 Arm 1, Dose Level-1: Lenalidomide 2.5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 200 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
|
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide
n=6 Participants
T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 1 Arm 1, Dose Level 1: Lenalidomide 5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
|
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide
n=6 Participants
T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 2 Arm 1, Dose Level 2: Lenalidomide 10 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
|
Arm 1, Cohort 1, Dose Level 3 Dose Escalation
n=3 Participants
T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 3 Arm 1, Dose Level 3: Lenalidomide 15 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
|
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide
n=3 Participants
T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 4 Arm 1, Dose Level 4: Lenalidomide 20 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
|
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide
n=2 Participants
T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 2 Arm 2, Dose Level 2: Lenalidomide by oral intake at maximum tolerated dose (MTD) on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.
|
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide
n=1 Participants
T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 4 Arm 2, Dose Level 4: Lenalidomide by oral intake at maximum tolerated dose (MTD) Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.
|
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide
n=3 Participants
T-cell Malignancies, Dose Expansion, Arm 3, Dose Level 4 Arm 3, Dose Level 4: Lenalidomide 20 mg maximum tolerated dose (MTD) by oral intake at on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
0 Participants
n=269 Participants
|
0 Participants
n=530 Participants
|
0 Participants
n=170 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=1 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=35 Participants
|
4 Participants
n=4328 Participants
|
5 Participants
n=8687 Participants
|
3 Participants
n=269 Participants
|
3 Participants
n=530 Participants
|
1 Participants
n=170 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=11 Participants
|
19 Participants
n=1 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=35 Participants
|
2 Participants
n=4328 Participants
|
1 Participants
n=8687 Participants
|
0 Participants
n=269 Participants
|
0 Participants
n=530 Participants
|
1 Participants
n=170 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=11 Participants
|
7 Participants
n=1 Participants
|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 15.56 • n=35 Participants
|
63.17 years
STANDARD_DEVIATION 11.46 • n=4328 Participants
|
55.67 years
STANDARD_DEVIATION 8.07 • n=8687 Participants
|
46.33 years
STANDARD_DEVIATION 14.19 • n=269 Participants
|
46.67 years
STANDARD_DEVIATION 16.29 • n=530 Participants
|
66.5 years
STANDARD_DEVIATION 9.19 • n=170 Participants
|
65 years
STANDARD_DEVIATION 0 • n=7 Participants
|
62.67 years
STANDARD_DEVIATION 21.73 • n=11 Participants
|
58 years
STANDARD_DEVIATION 13.46 • n=1 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=35 Participants
|
2 Participants
n=4328 Participants
|
2 Participants
n=8687 Participants
|
1 Participants
n=269 Participants
|
0 Participants
n=530 Participants
|
1 Participants
n=170 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=11 Participants
|
7 Participants
n=1 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=35 Participants
|
4 Participants
n=4328 Participants
|
4 Participants
n=8687 Participants
|
2 Participants
n=269 Participants
|
3 Participants
n=530 Participants
|
1 Participants
n=170 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=11 Participants
|
19 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
0 Participants
n=269 Participants
|
0 Participants
n=530 Participants
|
0 Participants
n=170 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=35 Participants
|
2 Participants
n=4328 Participants
|
1 Participants
n=8687 Participants
|
0 Participants
n=269 Participants
|
0 Participants
n=530 Participants
|
0 Participants
n=170 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=11 Participants
|
4 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
0 Participants
n=269 Participants
|
0 Participants
n=530 Participants
|
0 Participants
n=170 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=35 Participants
|
1 Participants
n=4328 Participants
|
3 Participants
n=8687 Participants
|
2 Participants
n=269 Participants
|
0 Participants
n=530 Participants
|
1 Participants
n=170 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=11 Participants
|
10 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
White
|
0 Participants
n=35 Participants
|
2 Participants
n=4328 Participants
|
2 Participants
n=8687 Participants
|
1 Participants
n=269 Participants
|
2 Participants
n=530 Participants
|
1 Participants
n=170 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=11 Participants
|
8 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
More Than One Race
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
0 Participants
n=269 Participants
|
1 Participants
n=530 Participants
|
0 Participants
n=170 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=11 Participants
|
2 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
Race Unknown or Not Reported
|
0 Participants
n=35 Participants
|
1 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
0 Participants
n=269 Participants
|
0 Participants
n=530 Participants
|
0 Participants
n=170 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=11 Participants
|
2 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
0 Participants
n=269 Participants
|
0 Participants
n=530 Participants
|
0 Participants
n=170 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=35 Participants
|
1 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
0 Participants
n=269 Participants
|
1 Participants
n=530 Participants
|
0 Participants
n=170 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=11 Participants
|
3 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
2 Participants
n=35 Participants
|
5 Participants
n=4328 Participants
|
6 Participants
n=8687 Participants
|
3 Participants
n=269 Participants
|
2 Participants
n=530 Participants
|
2 Participants
n=170 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=11 Participants
|
23 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
Ethnicity Unknown or Not Reported
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
0 Participants
n=269 Participants
|
0 Participants
n=530 Participants
|
0 Participants
n=170 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=1 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=35 Participants
|
6 participants
n=4328 Participants
|
6 participants
n=8687 Participants
|
3 participants
n=269 Participants
|
3 participants
n=530 Participants
|
2 participants
n=170 Participants
|
1 participants
n=7 Participants
|
3 participants
n=11 Participants
|
26 participants
n=1 Participants
|
PRIMARY outcome
Timeframe: 21 daysThe MTD is the dose level at which no more than 1 of up to 6 participants experience dose-limiting toxicity (DLT) during the DLT evaluation window(s), or the dose below that at which at least 2 (of ≤6) participants have DLT. A DLT is defined as any treatment-emergent and related severe (grade ≥3) toxicity related to lenalidomide, romidepsin and/or CC-486 (5-azacitidine) and occurring during the maximum tolerated dose (MTD) observation time, defined as day -7 until end of cycle 1 (normally day 22).
Outcome measures
| Measure |
All Participants
n=26 Participants
All participants who completed at least one cycle (21 days) of treatment.
|
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's
Arm 1, Cohort 1, Dose Level -1: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's
Arm 1, Cohort 1, Dose Level 1: Serious AE's
|
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's
Arm 1, Cohort 1, Dose Level 1: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's
Arm 1, Cohort 1, Dose Level 2: Serious AE's
|
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's
Arm 1, Cohort 1, Dose Level 2: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's
Arm 1, Cohort 1, Dose Level 3: Serious AE's
|
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's
Arm 1, Cohort 1, Dose Level 3: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's
Arm 1, Cohort 1, Dose Level 4: Serious AE's
|
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's
Arm 1, Cohort 1, Dose Level 4: Non-Serious AE's
|
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's
Arm 2, Cohort 2, Dose Level 2: Serious AE's
|
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's
Arm 2, Cohort 2, Dose Level 2: Non-Serious AE's
|
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's
Arm 2, Cohort 2, Dose Level 4: Serious AE's
|
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's
Arm 2, Cohort 2, Dose Level 4: Non-Serious AE's
|
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's
Arm 3, Cohort 2, Dose Level 4: Serious AE's
|
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's
Arm 3, Cohort 2, Dose Level 4: Non-Serious AE's
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD)
|
20 mg/day
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 6 cycles (each cycle is 28 days)Rate and severity of AEs will be summarized by grade and type of toxicity. Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event.
Outcome measures
| Measure |
All Participants
n=2 Participants
All participants who completed at least one cycle (21 days) of treatment.
|
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's
n=2 Participants
Arm 1, Cohort 1, Dose Level -1: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's
n=6 Participants
Arm 1, Cohort 1, Dose Level 1: Serious AE's
|
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's
n=6 Participants
Arm 1, Cohort 1, Dose Level 1: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's
n=6 Participants
Arm 1, Cohort 1, Dose Level 2: Serious AE's
|
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's
n=6 Participants
Arm 1, Cohort 1, Dose Level 2: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's
n=3 Participants
Arm 1, Cohort 1, Dose Level 3: Serious AE's
|
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's
n=3 Participants
Arm 1, Cohort 1, Dose Level 3: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's
n=3 Participants
Arm 1, Cohort 1, Dose Level 4: Serious AE's
|
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's
n=3 Participants
Arm 1, Cohort 1, Dose Level 4: Non-Serious AE's
|
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's
n=2 Participants
Arm 2, Cohort 2, Dose Level 2: Serious AE's
|
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's
n=2 Participants
Arm 2, Cohort 2, Dose Level 2: Non-Serious AE's
|
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's
n=1 Participants
Arm 2, Cohort 2, Dose Level 4: Serious AE's
|
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's
n=1 Participants
Arm 2, Cohort 2, Dose Level 4: Non-Serious AE's
|
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's
n=3 Participants
Arm 3, Cohort 2, Dose Level 4: Serious AE's
|
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's
n=3 Participants
Arm 3, Cohort 2, Dose Level 4: Non-Serious AE's
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity
Grade 4 Adrenal insufficiency
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity
Grade 1 Hypotension
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity
Grade 2 Vomiting
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
3 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
5 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity
Grade 3 Atrial fibrillation
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity
Grade 3 Adrenal insufficiency
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity
Grade 1 Heart failure
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity
Grade 2 Fatigue
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
3 adverse events
|
0 adverse events
|
4 adverse events
|
0 adverse events
|
5 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity
Grade 2 Nausea
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
6 adverse events
|
0 adverse events
|
3 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity
Grade 2 Neoplasms benign, malignant&unspecified(incl cysts&polyps)Other specify tumor flare reaction
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity
Grade 2 Pain in extremity
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity
Grade 3 Anemia
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
4 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
7 adverse events
|
0 adverse events
|
6 adverse events
|
0 adverse events
|
3 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity
Grade 3 Anorexia
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity
Grade 3 Blood bilirubin increased
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity
Grade 3 Hepatobiliary disorders - Other specify, Drug-Induced liver injury
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity
Grade 3 Rhabdomyolysis
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
PRIMARY outcome
Timeframe: 6 cycles (each cycle is 28 days)Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event.
Outcome measures
| Measure |
All Participants
n=2 Participants
All participants who completed at least one cycle (21 days) of treatment.
|
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's
n=6 Participants
Arm 1, Cohort 1, Dose Level -1: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's
n=6 Participants
Arm 1, Cohort 1, Dose Level 1: Serious AE's
|
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's
n=3 Participants
Arm 1, Cohort 1, Dose Level 1: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's
n=3 Participants
Arm 1, Cohort 1, Dose Level 2: Serious AE's
|
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's
n=2 Participants
Arm 1, Cohort 1, Dose Level 2: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's
n=1 Participants
Arm 1, Cohort 1, Dose Level 3: Serious AE's
|
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's
n=3 Participants
Arm 1, Cohort 1, Dose Level 3: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's
Arm 1, Cohort 1, Dose Level 4: Serious AE's
|
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's
Arm 1, Cohort 1, Dose Level 4: Non-Serious AE's
|
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's
Arm 2, Cohort 2, Dose Level 2: Serious AE's
|
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's
Arm 2, Cohort 2, Dose Level 2: Non-Serious AE's
|
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's
Arm 2, Cohort 2, Dose Level 4: Serious AE's
|
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's
Arm 2, Cohort 2, Dose Level 4: Non-Serious AE's
|
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's
Arm 3, Cohort 2, Dose Level 4: Serious AE's
|
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's
Arm 3, Cohort 2, Dose Level 4: Non-Serious AE's
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Treatment Emergent Grades 3, 4 and/or 5 Adverse Events Possibly Related to Drug Grouped by Severity
Grade 5
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Treatment Emergent Grades 3, 4 and/or 5 Adverse Events Possibly Related to Drug Grouped by Severity
Grade 3
|
13 adverse events
|
9 adverse events
|
0 adverse events
|
4 adverse events
|
1 adverse events
|
4 adverse events
|
1 adverse events
|
4 adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Treatment Emergent Grades 3, 4 and/or 5 Adverse Events Possibly Related to Drug Grouped by Severity
Grade 4
|
4 adverse events
|
2 adverse events
|
0 adverse events
|
4 adverse events
|
1 adverse events
|
4 adverse events
|
0 adverse events
|
3 adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 6 cycles (each cycle is 28 days)Treatment emergent grades 3, 4, and/or 5 adverse events possibly related grouped by relationship to the study drug (e.g., lenalidomide, romidepsin, CC-486 (5-azacitidine) in any combinations) assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 3 is severe. Grade 4 is life threatening. Grade 5 is death related to adverse event.
Outcome measures
| Measure |
All Participants
n=2 Participants
All participants who completed at least one cycle (21 days) of treatment.
|
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's
n=2 Participants
Arm 1, Cohort 1, Dose Level -1: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's
n=2 Participants
Arm 1, Cohort 1, Dose Level 1: Serious AE's
|
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's
n=2 Participants
Arm 1, Cohort 1, Dose Level 1: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's
n=6 Participants
Arm 1, Cohort 1, Dose Level 2: Serious AE's
|
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's
n=6 Participants
Arm 1, Cohort 1, Dose Level 2: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's
n=6 Participants
Arm 1, Cohort 1, Dose Level 3: Serious AE's
|
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's
n=6 Participants
Arm 1, Cohort 1, Dose Level 3: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's
n=6 Participants
Arm 1, Cohort 1, Dose Level 4: Serious AE's
|
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's
n=6 Participants
Arm 1, Cohort 1, Dose Level 4: Non-Serious AE's
|
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's
n=6 Participants
Arm 2, Cohort 2, Dose Level 2: Serious AE's
|
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's
n=6 Participants
Arm 2, Cohort 2, Dose Level 2: Non-Serious AE's
|
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's
Arm 2, Cohort 2, Dose Level 4: Serious AE's
|
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's
Arm 2, Cohort 2, Dose Level 4: Non-Serious AE's
|
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's
Arm 3, Cohort 2, Dose Level 4: Serious AE's
|
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's
Arm 3, Cohort 2, Dose Level 4: Non-Serious AE's
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination
Grade 3 Non-serious White blood cell decreased
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
—
|
—
|
—
|
—
|
|
Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination
Grade 3 Non-serious Fatigue
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
—
|
—
|
—
|
—
|
|
Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination
Grade 3 Serious Anorexia
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
—
|
—
|
—
|
—
|
|
Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination
Grade 3 Serious Atrial fibrillation
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
—
|
—
|
—
|
—
|
|
Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination
Grade 4 or 5 Any Serious Adverse Event
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
—
|
—
|
—
|
—
|
|
Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination
Grade 3 Non-serious Anemia
|
2 adverse events
|
2 adverse events
|
2 adverse events
|
2 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
—
|
—
|
—
|
—
|
|
Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination
Grade 3 Non-serious Lymphocyte count decreased
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
—
|
—
|
—
|
—
|
|
Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination
Grade 3 Non-serious Platelet count decreased
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
—
|
—
|
—
|
—
|
|
Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination
Grade 3 Non-serious Ejection fraction decreased
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
—
|
—
|
—
|
—
|
|
Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination
Grade 3 Non-serious Hypokalemia
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
—
|
—
|
—
|
—
|
|
Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination
Grade 4 Non-serious Platelet count decreased
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
—
|
—
|
—
|
—
|
|
Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination
Grade 4 White blood cell decreased
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
2 adverse events
|
2 adverse events
|
2 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
—
|
—
|
—
|
—
|
|
Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination
Grade 3 Non-serious Neutrophil count decreased
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
4 adverse events
|
4 adverse events
|
4 adverse events
|
4 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
—
|
—
|
—
|
—
|
|
Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination
Grade 3 Non-Serious Platelet count decreased
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
3 adverse events
|
3 adverse events
|
3 adverse events
|
3 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
—
|
—
|
—
|
—
|
|
Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination
Grade 4 Non-serious Neutrophil count decreased
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
2 adverse events
|
2 adverse events
|
2 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
—
|
—
|
—
|
—
|
|
Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination
Grade 3 Non-serious Weight loss
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 6 cycles (each cycle is 28 days)Treatment emergent grades 3, 4, and/or 5 adverse events possibly related grouped by relationship to the study drug (e.g., lenalidomide, romidepsin, CC-486 (5-azacitidine) in any combinations) assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 3 is severe. Grade 4 is life threatening. Grade 5 is death related to adverse event.
Outcome measures
| Measure |
All Participants
n=3 Participants
All participants who completed at least one cycle (21 days) of treatment.
|
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's
n=3 Participants
Arm 1, Cohort 1, Dose Level -1: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's
n=3 Participants
Arm 1, Cohort 1, Dose Level 1: Serious AE's
|
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's
n=3 Participants
Arm 1, Cohort 1, Dose Level 1: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's
n=3 Participants
Arm 1, Cohort 1, Dose Level 2: Serious AE's
|
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's
n=3 Participants
Arm 1, Cohort 1, Dose Level 2: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's
n=3 Participants
Arm 1, Cohort 1, Dose Level 3: Serious AE's
|
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's
n=3 Participants
Arm 1, Cohort 1, Dose Level 3: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's
Arm 1, Cohort 1, Dose Level 4: Serious AE's
|
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's
Arm 1, Cohort 1, Dose Level 4: Non-Serious AE's
|
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's
Arm 2, Cohort 2, Dose Level 2: Serious AE's
|
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's
Arm 2, Cohort 2, Dose Level 2: Non-Serious AE's
|
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's
Arm 2, Cohort 2, Dose Level 4: Serious AE's
|
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's
Arm 2, Cohort 2, Dose Level 4: Non-Serious AE's
|
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's
Arm 3, Cohort 2, Dose Level 4: Serious AE's
|
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's
Arm 3, Cohort 2, Dose Level 4: Non-Serious AE's
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination
Grade 3 Serious Hepatobiliary disorders - Other specify, Drug-Induced liver injury
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination
Grade 3 Non-serious Blood bilirubin increased
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination
Grade 3 Non-serious CPK increased
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination
Grade 3 Non-serious Fatigue
|
1 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination
Grade 3 Non-serious Hypotension
|
1 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination
Grade 3 Non-serious Neutrophil count decreased
|
3 adverse events
|
3 adverse events
|
3 adverse events
|
3 adverse events
|
2 adverse events
|
2 adverse events
|
2 adverse events
|
2 adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination
Grade 3 White blood cell decreased
|
3 adverse events
|
3 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination
Grade 4 Lymphocyte count decreased
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
2 adverse events
|
2 adverse events
|
2 adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination
Grade 3 Serious Blood bilirubin increased
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination
Grade 3 Serious Rhabdomyolysis
|
2 adverse events
|
0 adverse events
|
2 adverse events
|
2 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination
Any Grade 4 and/or 5 Serious Adverse Event
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination
Grade 3 Non-serious Acute kidney injury
|
1 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination
Grade 3 Platelet count decreased
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination
Grade 3 Non-serious Aspartate aminotransferase increased
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination
Grade 4 CPK increased
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
2 adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination
Grade 3 Non-serious Alanine aminotransferase increased
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination
Grade 3 Non-serious Anemia
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination
Grade 3 Non-serious Lymphocyte count decreased
|
4 adverse events
|
4 adverse events
|
4 adverse events
|
4 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 6 cycles (each cycle is 28 days)Treatment emergent grades 3, 4, and/or 5 adverse events possibly related grouped by relationship to the study drug (e.g., lenalidomide, romidepsin, CC-486 (5-azacitidine) in any combinations) assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 3 is severe. Grade 4 is life threatening. Grade 5 is death related to adverse event.
Outcome measures
| Measure |
All Participants
n=2 Participants
All participants who completed at least one cycle (21 days) of treatment.
|
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's
n=2 Participants
Arm 1, Cohort 1, Dose Level -1: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's
n=2 Participants
Arm 1, Cohort 1, Dose Level 1: Serious AE's
|
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's
n=2 Participants
Arm 1, Cohort 1, Dose Level 1: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's
n=1 Participants
Arm 1, Cohort 1, Dose Level 2: Serious AE's
|
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's
n=1 Participants
Arm 1, Cohort 1, Dose Level 2: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's
n=1 Participants
Arm 1, Cohort 1, Dose Level 3: Serious AE's
|
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's
n=1 Participants
Arm 1, Cohort 1, Dose Level 3: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's
n=3 Participants
Arm 1, Cohort 1, Dose Level 4: Serious AE's
|
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's
n=3 Participants
Arm 1, Cohort 1, Dose Level 4: Non-Serious AE's
|
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's
n=3 Participants
Arm 2, Cohort 2, Dose Level 2: Serious AE's
|
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's
n=3 Participants
Arm 2, Cohort 2, Dose Level 2: Non-Serious AE's
|
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's
Arm 2, Cohort 2, Dose Level 4: Serious AE's
|
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's
Arm 2, Cohort 2, Dose Level 4: Non-Serious AE's
|
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's
Arm 3, Cohort 2, Dose Level 4: Serious AE's
|
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's
Arm 3, Cohort 2, Dose Level 4: Non-Serious AE's
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination
Any Grade 3, 4, and/or 5 Serious Adverse Event
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
—
|
—
|
—
|
—
|
|
Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination
Grade 3 Non-serious Anemia
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
7 adverse events
|
7 adverse events
|
7 adverse events
|
7 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
—
|
—
|
—
|
—
|
|
Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination
Grade 3 Non-serious Anorexia
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
—
|
—
|
—
|
—
|
|
Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination
Grade 3 Non-serious Hypokalemia
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
—
|
—
|
—
|
—
|
|
Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination
Grade 3 Platelet count decreased
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
4 adverse events
|
4 adverse events
|
4 adverse events
|
4 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
—
|
—
|
—
|
—
|
|
Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination
Grade 4 Neutrophil count decreased
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
—
|
—
|
—
|
—
|
|
Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination
Grade 4 Platelet count decreased
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
3 adverse events
|
3 adverse events
|
3 adverse events
|
3 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 cycles (each cycle is 28 days)The response rate will be estimated using the Kaplan-Meier curve and reported along with a 95% confidence interval. Response was measured by the Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria. Complete response (CR) is disappearance of all target lesions and all nodes with long axis \<10mm. Partial response (PR) is a ≥30% decrease in the sum of longest diameters of target lesions but not a CR.
Outcome measures
| Measure |
All Participants
n=2 Participants
All participants who completed at least one cycle (21 days) of treatment.
|
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's
n=6 Participants
Arm 1, Cohort 1, Dose Level -1: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's
n=6 Participants
Arm 1, Cohort 1, Dose Level 1: Serious AE's
|
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's
n=3 Participants
Arm 1, Cohort 1, Dose Level 1: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's
n=3 Participants
Arm 1, Cohort 1, Dose Level 2: Serious AE's
|
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's
n=2 Participants
Arm 1, Cohort 1, Dose Level 2: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's
n=1 Participants
Arm 1, Cohort 1, Dose Level 3: Serious AE's
|
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's
n=3 Participants
Arm 1, Cohort 1, Dose Level 3: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's
Arm 1, Cohort 1, Dose Level 4: Serious AE's
|
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's
Arm 1, Cohort 1, Dose Level 4: Non-Serious AE's
|
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's
Arm 2, Cohort 2, Dose Level 2: Serious AE's
|
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's
Arm 2, Cohort 2, Dose Level 2: Non-Serious AE's
|
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's
Arm 2, Cohort 2, Dose Level 4: Serious AE's
|
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's
Arm 2, Cohort 2, Dose Level 4: Non-Serious AE's
|
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's
Arm 3, Cohort 2, Dose Level 4: Serious AE's
|
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's
Arm 3, Cohort 2, Dose Level 4: Non-Serious AE's
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Response Rate (Complete Response + Partial Response)
Complete Response
|
50 percentage of participants
Interval 47.3 to 52.7
|
16.6 percentage of participants
Interval 15.3 to 18.0
|
33.3 percentage of participants
Interval 31.8 to 34.8
|
66 percentage of participants
Interval 64.0 to 68.0
|
100 percentage of participants
Interval 98.0 to 100.0
|
50 percentage of participants
Interval 47.3 to 52.7
|
100 percentage of participants
Interval 100.0 to 100.0
|
100 percentage of participants
Interval 97.3 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Overall Response Rate (Complete Response + Partial Response)
Partial Response
|
50 percentage of participants
Interval 47.3 to 52.7
|
0 percentage of participants
Interval 0.0 to 0.0
|
33.3 percentage of participants
Interval 31.8 to 34.8
|
66 percentage of participants
Interval 64.0 to 68.0
|
100 percentage of participants
Interval 98.0 to 100.0
|
50 percentage of participants
Interval 47.3 to 52.7
|
0 percentage of participants
Interval 0.0 to 0.0
|
50 percentage of participants
Interval 47.3 to 52.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to a median of 13.1 monthsPFS will be estimated using the Kaplan-Meier curve and reported along with a 95% confidence interval. PFS is defined as the duration of time from the date of study enrollment until time of disease relapse, disease progression, or death, whichever occurs first measured by the Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria. Progressive disease is \>20% increase in the sum of longest diameters of target lesions. Disease relapse is defined as new areas of disease or \>50% increase in growth of target lesion.
Outcome measures
| Measure |
All Participants
n=2 Participants
All participants who completed at least one cycle (21 days) of treatment.
|
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's
n=6 Participants
Arm 1, Cohort 1, Dose Level -1: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's
n=6 Participants
Arm 1, Cohort 1, Dose Level 1: Serious AE's
|
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's
n=3 Participants
Arm 1, Cohort 1, Dose Level 1: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's
n=3 Participants
Arm 1, Cohort 1, Dose Level 2: Serious AE's
|
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's
n=2 Participants
Arm 1, Cohort 1, Dose Level 2: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's
n=1 Participants
Arm 1, Cohort 1, Dose Level 3: Serious AE's
|
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's
n=3 Participants
Arm 1, Cohort 1, Dose Level 3: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's
Arm 1, Cohort 1, Dose Level 4: Serious AE's
|
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's
Arm 1, Cohort 1, Dose Level 4: Non-Serious AE's
|
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's
Arm 2, Cohort 2, Dose Level 2: Serious AE's
|
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's
Arm 2, Cohort 2, Dose Level 2: Non-Serious AE's
|
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's
Arm 2, Cohort 2, Dose Level 4: Serious AE's
|
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's
Arm 2, Cohort 2, Dose Level 4: Non-Serious AE's
|
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's
Arm 3, Cohort 2, Dose Level 4: Serious AE's
|
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's
Arm 3, Cohort 2, Dose Level 4: Non-Serious AE's
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Progression-free Survival (PFS) in Months Reported Along With a 95% Confidence Interval
|
5.3 Months
Interval 4.8 to 5.8
|
1.7 Months
Interval 1.4 to 2.0
|
NA Months
The median was not reached as there were not enough events.
|
3.7 Months
Interval 3.1 to 4.3
|
9.2 Months
Interval 8.6 to 10.0
|
3.6 Months
Interval 3.3 to 3.9
|
13.1 Months
Interval 13.1 to 13.1
|
3.4 Months
Interval 3.0 to 3.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 cycles (each cycle is 28 days)CRR will be estimated using the Kaplan-Meier curve and reported along with a 95% confidence interval. Response was measured by the Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria. Complete response (CR) is disappearance of all target lesions and all nodes with long axis \<10mm.
Outcome measures
| Measure |
All Participants
n=2 Participants
All participants who completed at least one cycle (21 days) of treatment.
|
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's
n=6 Participants
Arm 1, Cohort 1, Dose Level -1: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's
n=6 Participants
Arm 1, Cohort 1, Dose Level 1: Serious AE's
|
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's
n=3 Participants
Arm 1, Cohort 1, Dose Level 1: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's
n=3 Participants
Arm 1, Cohort 1, Dose Level 2: Serious AE's
|
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's
n=2 Participants
Arm 1, Cohort 1, Dose Level 2: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's
n=1 Participants
Arm 1, Cohort 1, Dose Level 3: Serious AE's
|
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's
n=3 Participants
Arm 1, Cohort 1, Dose Level 3: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's
Arm 1, Cohort 1, Dose Level 4: Serious AE's
|
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's
Arm 1, Cohort 1, Dose Level 4: Non-Serious AE's
|
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's
Arm 2, Cohort 2, Dose Level 2: Serious AE's
|
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's
Arm 2, Cohort 2, Dose Level 2: Non-Serious AE's
|
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's
Arm 2, Cohort 2, Dose Level 4: Serious AE's
|
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's
Arm 2, Cohort 2, Dose Level 4: Non-Serious AE's
|
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's
Arm 3, Cohort 2, Dose Level 4: Serious AE's
|
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's
Arm 3, Cohort 2, Dose Level 4: Non-Serious AE's
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Complete Response Rate (CRR)
|
0 percentage of participants
Interval 0.0 to 0.0
|
16.6 percentage of participants
Interval 15.3 to 18.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
100 percentage of participants
Interval 100.0 to 100.0
|
50 percentage of participants
Interval 47.3 to 52.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to a median of 11.7 monthsDOR will be determined and reported along with a 95% confidence interval. DOR is measured from the time measurement criteria are met for complete response (CR) or partial response (PR (whichever is recorded first) until the first date that recurrent or progressive disease is objectively documented. Response was measured by the Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria. Complete response (CR) is disappearance of all target lesions and all nodes with long axis \<10mm. Partial response (PR) is a ≥30% decrease in the sum of longest diameters of target lesions but not a CR. Progressive disease is \>20% increase in the sum of longest diameters of target lesions.
Outcome measures
| Measure |
All Participants
n=2 Participants
All participants who completed at least one cycle (21 days) of treatment.
|
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's
n=6 Participants
Arm 1, Cohort 1, Dose Level -1: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's
n=6 Participants
Arm 1, Cohort 1, Dose Level 1: Serious AE's
|
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's
n=3 Participants
Arm 1, Cohort 1, Dose Level 1: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's
n=3 Participants
Arm 1, Cohort 1, Dose Level 2: Serious AE's
|
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's
n=2 Participants
Arm 1, Cohort 1, Dose Level 2: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's
n=1 Participants
Arm 1, Cohort 1, Dose Level 3: Serious AE's
|
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's
n=3 Participants
Arm 1, Cohort 1, Dose Level 3: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's
Arm 1, Cohort 1, Dose Level 4: Serious AE's
|
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's
Arm 1, Cohort 1, Dose Level 4: Non-Serious AE's
|
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's
Arm 2, Cohort 2, Dose Level 2: Serious AE's
|
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's
Arm 2, Cohort 2, Dose Level 2: Non-Serious AE's
|
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's
Arm 2, Cohort 2, Dose Level 4: Serious AE's
|
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's
Arm 2, Cohort 2, Dose Level 4: Non-Serious AE's
|
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's
Arm 3, Cohort 2, Dose Level 4: Serious AE's
|
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's
Arm 3, Cohort 2, Dose Level 4: Non-Serious AE's
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DOR) in Months Reported Along With a 95% Confidence Interval
|
5.8 Months
Interval 5.2 to 6.4
|
NA Months
The median was not reached as there were not enough events.
|
NA Months
The median was not reached as there were not enough events.
|
2.1 Months
Interval 1.8 to 2.4
|
6.0 Months
Interval 5.7 to 6.3
|
3.4 Months
Interval 3.0 to 3.8
|
11.7 Months
Interval 11.7 to 11.7
|
1.5 Months
Interval 1.1 to 1.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to a median of 8.7 monthsOS will be estimated using the Kaplan-Meier curve and reported along with a 95% confidence interval. OS is defined as the time from the date of study enrollment until time of death from any cause.
Outcome measures
| Measure |
All Participants
n=2 Participants
All participants who completed at least one cycle (21 days) of treatment.
|
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's
n=6 Participants
Arm 1, Cohort 1, Dose Level -1: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's
n=6 Participants
Arm 1, Cohort 1, Dose Level 1: Serious AE's
|
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's
n=3 Participants
Arm 1, Cohort 1, Dose Level 1: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's
n=3 Participants
Arm 1, Cohort 1, Dose Level 2: Serious AE's
|
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's
n=2 Participants
Arm 1, Cohort 1, Dose Level 2: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's
n=1 Participants
Arm 1, Cohort 1, Dose Level 3: Serious AE's
|
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's
n=3 Participants
Arm 1, Cohort 1, Dose Level 3: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's
Arm 1, Cohort 1, Dose Level 4: Serious AE's
|
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's
Arm 1, Cohort 1, Dose Level 4: Non-Serious AE's
|
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's
Arm 2, Cohort 2, Dose Level 2: Serious AE's
|
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's
Arm 2, Cohort 2, Dose Level 2: Non-Serious AE's
|
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's
Arm 2, Cohort 2, Dose Level 4: Serious AE's
|
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's
Arm 2, Cohort 2, Dose Level 4: Non-Serious AE's
|
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's
Arm 3, Cohort 2, Dose Level 4: Serious AE's
|
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's
Arm 3, Cohort 2, Dose Level 4: Non-Serious AE's
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
8.7 Months
Interval 8.1 to 9.3
|
4.6 Months
Interval 4.2 to 5.0
|
NA Months
The median was not reached as there were not enough events.
|
NA Months
The median was not reached as there were not enough events.
|
NA Months
The median was not reached as there were not enough events.
|
4.5 Months
Interval 3.9 to 5.1
|
NA Months
The median was not reached as there were not enough events.
|
NA Months
The median was not reached as there were not enough events.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 3.5 yearsHere is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
All Participants
n=2 Participants
All participants who completed at least one cycle (21 days) of treatment.
|
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's
n=6 Participants
Arm 1, Cohort 1, Dose Level -1: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's
n=6 Participants
Arm 1, Cohort 1, Dose Level 1: Serious AE's
|
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's
n=3 Participants
Arm 1, Cohort 1, Dose Level 1: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's
n=3 Participants
Arm 1, Cohort 1, Dose Level 2: Serious AE's
|
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's
n=2 Participants
Arm 1, Cohort 1, Dose Level 2: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's
n=1 Participants
Arm 1, Cohort 1, Dose Level 3: Serious AE's
|
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's
n=3 Participants
Arm 1, Cohort 1, Dose Level 3: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's
Arm 1, Cohort 1, Dose Level 4: Serious AE's
|
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's
Arm 1, Cohort 1, Dose Level 4: Non-Serious AE's
|
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's
Arm 2, Cohort 2, Dose Level 2: Serious AE's
|
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's
Arm 2, Cohort 2, Dose Level 2: Non-Serious AE's
|
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's
Arm 2, Cohort 2, Dose Level 4: Serious AE's
|
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's
Arm 2, Cohort 2, Dose Level 4: Non-Serious AE's
|
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's
Arm 3, Cohort 2, Dose Level 4: Serious AE's
|
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's
Arm 3, Cohort 2, Dose Level 4: Non-Serious AE's
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0).
|
2 Participants
|
6 Participants
|
6 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day -7 until end of cycle 1 (normally day 22)A DLT is defined as any treatment-emergent and related severe (grade ≥3) toxicity related to lenalidomide, romidepsin and/or CC-486 (5-azacitidine) and occurring during the maximum tolerated dose (MTD) observation time, defined as day -7 until end of cycle 1 (normally day 22). Grade 4 is life threatening, and Grade 5 is death related to adverse event. Serious toxicity was assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0).
Outcome measures
| Measure |
All Participants
n=2 Participants
All participants who completed at least one cycle (21 days) of treatment.
|
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's
n=6 Participants
Arm 1, Cohort 1, Dose Level -1: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's
n=6 Participants
Arm 1, Cohort 1, Dose Level 1: Serious AE's
|
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's
n=3 Participants
Arm 1, Cohort 1, Dose Level 1: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's
n=3 Participants
Arm 1, Cohort 1, Dose Level 2: Serious AE's
|
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's
n=2 Participants
Arm 1, Cohort 1, Dose Level 2: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's
n=1 Participants
Arm 1, Cohort 1, Dose Level 3: Serious AE's
|
Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's
n=3 Participants
Arm 1, Cohort 1, Dose Level 3: Non-Serious AE's
|
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's
Arm 1, Cohort 1, Dose Level 4: Serious AE's
|
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's
Arm 1, Cohort 1, Dose Level 4: Non-Serious AE's
|
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's
Arm 2, Cohort 2, Dose Level 2: Serious AE's
|
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's
Arm 2, Cohort 2, Dose Level 2: Non-Serious AE's
|
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's
Arm 2, Cohort 2, Dose Level 4: Serious AE's
|
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's
Arm 2, Cohort 2, Dose Level 4: Non-Serious AE's
|
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's
Arm 3, Cohort 2, Dose Level 4: Serious AE's
|
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's
Arm 3, Cohort 2, Dose Level 4: Non-Serious AE's
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With a Dose-limiting Toxicity (DLT)
Grade 4
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With a Dose-limiting Toxicity (DLT)
Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With a Dose-limiting Toxicity (DLT)
Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
00 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide
Serious events: 0 serious events
Other events: 2 other events
Deaths: 2 deaths
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide
Serious events: 2 serious events
Other events: 6 other events
Deaths: 3 deaths
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide
Serious events: 1 serious events
Other events: 6 other events
Deaths: 3 deaths
Arm 1, Cohort 1, Dose Level 3 Dose Escalation
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide
Serious events: 0 serious events
Other events: 2 other events
Deaths: 1 deaths
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide
n=2 participants at risk
T-cell Malignancies, Dose Escalation, Arm 1, Dose Level -1 Arm 1, Dose Level-1: Lenalidomide 2.5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 200 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
|
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide
n=6 participants at risk
T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 1 Arm 1, Dose Level 1: Lenalidomide 5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
|
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide
n=6 participants at risk
T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 2 Arm 1, Dose Level 2: Lenalidomide 10 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
|
Arm 1, Cohort 1, Dose Level 3 Dose Escalation
n=3 participants at risk
T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 3 Arm 1, Dose Level 3: Lenalidomide 15 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
|
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide
n=3 participants at risk
T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 4 Arm 1, Dose Level 4: Lenalidomide 20 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
|
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide
n=2 participants at risk
T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 2 Arm 2, Dose Level 2: Lenalidomide by oral intake at maximum tolerated dose (MTD) on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.
|
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide
n=1 participants at risk
T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 4 Arm 2, Dose Level 4: Lenalidomide by oral intake at maximum tolerated dose (MTD) Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.
|
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide
n=3 participants at risk
T-cell Malignancies, Dose Expansion, Arm 3, Dose Level 4 Arm 3, Dose Level 4: Lenalidomide 20 mg maximum tolerated dose (MTD) by oral intake at on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.
|
|---|---|---|---|---|---|---|---|---|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
General disorders
Fatigue
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Cardiac disorders
Heart failure
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify: Drug-Induced Liver Injury
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Vascular disorders
Hypotension
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
Other adverse events
| Measure |
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide
n=2 participants at risk
T-cell Malignancies, Dose Escalation, Arm 1, Dose Level -1 Arm 1, Dose Level-1: Lenalidomide 2.5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 200 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
|
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide
n=6 participants at risk
T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 1 Arm 1, Dose Level 1: Lenalidomide 5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
|
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide
n=6 participants at risk
T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 2 Arm 1, Dose Level 2: Lenalidomide 10 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
|
Arm 1, Cohort 1, Dose Level 3 Dose Escalation
n=3 participants at risk
T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 3 Arm 1, Dose Level 3: Lenalidomide 15 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
|
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide
n=3 participants at risk
T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 4 Arm 1, Dose Level 4: Lenalidomide 20 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
|
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide
n=2 participants at risk
T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 2 Arm 2, Dose Level 2: Lenalidomide by oral intake at maximum tolerated dose (MTD) on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.
|
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide
n=1 participants at risk
T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 4 Arm 2, Dose Level 4: Lenalidomide by oral intake at maximum tolerated dose (MTD) Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.
|
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide
n=3 participants at risk
T-cell Malignancies, Dose Expansion, Arm 3, Dose Level 4 Arm 3, Dose Level 4: Lenalidomide 20 mg maximum tolerated dose (MTD) by oral intake at on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
100.0%
2/2 • Number of events 2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
100.0%
1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Investigations
Alanine aminotransferase increased
|
100.0%
2/2 • Number of events 2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 7 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Investigations
Alkaline phosphatase increased
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
66.7%
2/3 • Number of events 2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
2/6 • Number of events 2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Gastrointestinal disorders
Anal pain
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
1/2 • Number of events 10 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
66.7%
4/6 • Number of events 16 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
66.7%
4/6 • Number of events 10 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
100.0%
3/3 • Number of events 14 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
66.7%
2/3 • Number of events 3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
100.0%
2/2 • Number of events 5 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
100.0%
1/1 • Number of events 18 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 5 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
100.0%
2/2 • Number of events 2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
2/6 • Number of events 3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
100.0%
3/3 • Number of events 4 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
66.7%
2/3 • Number of events 2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
100.0%
1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 4 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 9 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
100.0%
1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify: low iron level
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Investigations
CPK increased
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
General disorders
Chills
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Gastrointestinal disorders
Constipation
|
100.0%
2/2 • Number of events 4 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
50.0%
3/6 • Number of events 3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Investigations
Creatinine increased
|
50.0%
1/2 • Number of events 3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
66.7%
2/3 • Number of events 4 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
100.0%
1/1 • Number of events 2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Psychiatric disorders
Depression
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
2/6 • Number of events 2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
2/6 • Number of events 6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 4 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
66.7%
2/3 • Number of events 4 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
100.0%
1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
66.7%
2/3 • Number of events 2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Eye disorders
Dry eye
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Nervous system disorders
Dysgeusia
|
50.0%
1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
50.0%
3/6 • Number of events 4 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
66.7%
4/6 • Number of events 4 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
66.7%
2/3 • Number of events 2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
66.7%
2/3 • Number of events 2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Gastrointestinal disorders
Dysphagia
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
General disorders
Edema limbs
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
100.0%
1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Gastrointestinal disorders
Esophageal varices hemorrhage
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
100.0%
1/1 • Number of events 2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Eye disorders
Eye disorders - Other, specify: Corneal Thinning
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Eye disorders
Eye disorders - Other, specify: Itchy eyes
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Eye disorders
Eye disorders - Other, specify: Light Sensitivity
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Eye disorders
Eye disorders - Other, specify: double vision
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
General disorders
Fatigue
|
50.0%
1/2 • Number of events 3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
2/6 • Number of events 2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
66.7%
4/6 • Number of events 7 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
66.7%
2/3 • Number of events 6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
General disorders
Fever
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
50.0%
3/6 • Number of events 9 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
2/6 • Number of events 2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Vascular disorders
Flushing
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify: Increased thirst, Intermittent
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Nervous system disorders
Headache
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Vascular disorders
Hematoma
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Infections and infestations
Herpes simplex reactivation
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
100.0%
1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Vascular disorders
Hypertension
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
50.0%
1/2 • Number of events 6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
2/6 • Number of events 2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 5 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
50.0%
3/6 • Number of events 14 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
100.0%
3/3 • Number of events 4 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
66.7%
2/3 • Number of events 3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
100.0%
1/1 • Number of events 4 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
50.0%
1/2 • Number of events 3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
100.0%
1/1 • Number of events 5 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
2/6 • Number of events 2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 5 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
100.0%
1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
2/6 • Number of events 4 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Vascular disorders
Hypotension
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
2/6 • Number of events 3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
100.0%
1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
General disorders
Injection site reaction
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Investigations
Investigations - Other, specify: Decreased iron
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
General disorders
Localized edema
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Vascular disorders
Lymphedema
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Investigations
Lymphocyte count decreased
|
100.0%
2/2 • Number of events 11 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
100.0%
3/3 • Number of events 21 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
66.7%
2/3 • Number of events 2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Gastrointestinal disorders
Mucositis oral
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
50.0%
1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify: Fracture, compression
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Infections and infestations
Nail infection
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
2/2 • Number of events 2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
66.7%
4/6 • Number of events 5 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
66.7%
4/6 • Number of events 5 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
100.0%
3/3 • Number of events 8 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Nervous system disorders
Nervous system disorders - Other, specify: Migraine
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Investigations
Neutrophil count decreased
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
83.3%
5/6 • Number of events 25 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
83.3%
5/6 • Number of events 12 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
66.7%
2/3 • Number of events 11 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 7 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
100.0%
1/1 • Number of events 2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Musculoskeletal and connective tissue disorders
Non-cardiac chest pain
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
General disorders
Pain
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Nervous system disorders
Paresthesia
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Investigations
Platelet count decreased
|
100.0%
2/2 • Number of events 19 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
83.3%
5/6 • Number of events 23 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
66.7%
4/6 • Number of events 12 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
66.7%
2/3 • Number of events 10 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
66.7%
2/3 • Number of events 2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
100.0%
1/1 • Number of events 14 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
66.7%
2/3 • Number of events 12 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Cardiac disorders
Sinus bradycardia
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
2/6 • Number of events 3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
2/6 • Number of events 3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Infections and infestations
Skin infection
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
66.7%
2/3 • Number of events 3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Nervous system disorders
Tremor
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
100.0%
1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
2/6 • Number of events 2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
50.0%
1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Eye disorders
Uveitis
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
50.0%
3/6 • Number of events 7 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
50.0%
3/6 • Number of events 7 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
66.7%
2/3 • Number of events 5 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Infections and infestations
Vulval infection
|
50.0%
1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Investigations
Weight loss
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
2/6 • Number of events 3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
33.3%
2/6 • Number of events 6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
100.0%
3/3 • Number of events 10 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
|
Investigations
White blood cell decreased
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 4 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
16.7%
1/6 • Number of events 3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
66.7%
2/3 • Number of events 10 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
100.0%
3/3 • Number of events 6 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
0.00%
0/3 • All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place