Trial Outcomes & Findings for A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma (NCT NCT04181827)
NCT ID: NCT04181827
Last Updated: 2025-11-13
Results Overview
PFS: defined as time from date of randomization to date of first documented progressed disease (PD) as per International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occurred first. PD: increase of 25% from lowest response value: serum and urine M-component (absolute increase must be \>=0.5 grams per deciliter \[g/dL\] and \>=200 milligrams \[mg\] per 24 hours, respectively); only in participants without measurable serum and urine M-protein levels, difference between involved and uninvolved free light chain (FLC) levels (absolute increase of \>10 mg/dL); only in participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow plasma cell (PC)% (absolute increase of \>=10%), appearance of new lesion; definite development of new bone lesions or definite increase in size of existing bone lesions, \>=50% increase in circulating PCs (minimum of 200 cells per microliter \[uL\]) if this was only measure of disease.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
419 participants
Primary outcome timeframe
From randomization (Day 1) to either progressive disease or death, whichever occurred first (up to 3.9 years)
Results posted on
2025-11-13
Participant Flow
Currently results are reported until the primary completion date (01-May-2024). Results of remaining duration of the study will be reported after study completion.
Participant milestones
| Measure |
Arm A: Standard Therapy: PVd or DPd
Participants received either PVd or DPd as standard therapy. In pomalidomide, bortezomib and dexamethasone (PVd) treatment, participants received pomalidomide 4 milligrams (mg) orally (PO) on Days 1 to 14 in each treatment cycle; bortezomib 1.3 mg/meter square (m\^2) subcutaneous (SC) injection on Days 1, 4, 8 and 11 (Cycles 1 to 8) and on Days 1 and 8 (Cycle 9 onwards); and dexamethasone 20 mg (or 10 mg for participants aged greater than \[\>\] 75 years) PO on Days 1, 2, 4, 5, 8, 9, 11 and 12 (Cycles 1 to 8) and Days 1, 2, 8 and 9 (Cycle 9 onwards). Each treatment cycle of 21 days. In daratumumab, pomalidomide and dexamethasone (DPd) treatment, participants received daratumumab 1800 mg SC injection weekly on Days 1, 8, 15 and 22 (Cycle 1 and 2), every 2 weeks on Days 1 and 15 (Cycle 3 to 6) and every 4 weeks on Day 1 (Cycle 7 onwards); pomalidomide 4 mg PO on Days 1 to 21 (Cycle 1 onwards); dexamethasone 40 mg (or 20 mg for participants aged \>75 years) PO or intravenous(IV) weekly during Cycle 1-2 on Days 1, 8, 15, and 22 or split with 20 mg on Days 1, 2, 8, 9, 15, 16, 22, and 23. Each treatment cycle of 28 days. Participants continued to receive PVd or DPd until confirmed progressive disease (PD), death, intolerable toxicity, withdrawal of consent, or end of study, whichever occurred earlier.
|
Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel])
Participants received at least one cycle of bridging therapy, that is PVd: pomalidomide 4 mg PO on Days 1 to 14, bortezomib 1.3 mg/m\^2 SC injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg (or 10 mg for participants aged \>75 years) PO on Days 1, 2, 4, 5, 8, 9, 11, and 12; each treatment cycle of 21 days. DPd: daratumumab SC 1800 mg (co-formulated with rHuPH20) weekly on Days 1, 8, 15, and 22, pomalidomide 4 mg PO on Days 1 to 21, and dexamethasone PO or IV 40 mg (or 20 mg for participants aged \>75 years) weekly during Cycle 1-2 on Days 1, 8, 15, and 22 or split with 20 mg on Days 1, 2, 8, 9, 15, 16, 22, and 23. Each treatment cycle of 28 days. Additional cycles of bridging therapy was considered based on participant's clinical status and timing of availability of JNJ-68284528 (cilta-cel). Followed by bridging therapy, participants received conditioning regimen: cyclophosphamide 300 mg/m\^2 IV and fludarabine 30 mg/m\^2 IV daily, for 3 days on chimeric antigen receptor T cells (CAR-T) Day -5, -4, -3 (prior to JNJ-68284528 infusion), followed by JNJ-68284528 (cilta-cel) infusion 0.75\*10\^6 chimeric antigen receptor (CAR)-positive viable T cells per kilogram (kg) 5 to 7 days after the start of conditioning regimen.
|
|---|---|---|
|
Overall Study
STARTED
|
211
|
208
|
|
Overall Study
Treated (Safety Analysis Set)
|
208
|
208
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
211
|
208
|
Reasons for withdrawal
| Measure |
Arm A: Standard Therapy: PVd or DPd
Participants received either PVd or DPd as standard therapy. In pomalidomide, bortezomib and dexamethasone (PVd) treatment, participants received pomalidomide 4 milligrams (mg) orally (PO) on Days 1 to 14 in each treatment cycle; bortezomib 1.3 mg/meter square (m\^2) subcutaneous (SC) injection on Days 1, 4, 8 and 11 (Cycles 1 to 8) and on Days 1 and 8 (Cycle 9 onwards); and dexamethasone 20 mg (or 10 mg for participants aged greater than \[\>\] 75 years) PO on Days 1, 2, 4, 5, 8, 9, 11 and 12 (Cycles 1 to 8) and Days 1, 2, 8 and 9 (Cycle 9 onwards). Each treatment cycle of 21 days. In daratumumab, pomalidomide and dexamethasone (DPd) treatment, participants received daratumumab 1800 mg SC injection weekly on Days 1, 8, 15 and 22 (Cycle 1 and 2), every 2 weeks on Days 1 and 15 (Cycle 3 to 6) and every 4 weeks on Day 1 (Cycle 7 onwards); pomalidomide 4 mg PO on Days 1 to 21 (Cycle 1 onwards); dexamethasone 40 mg (or 20 mg for participants aged \>75 years) PO or intravenous(IV) weekly during Cycle 1-2 on Days 1, 8, 15, and 22 or split with 20 mg on Days 1, 2, 8, 9, 15, 16, 22, and 23. Each treatment cycle of 28 days. Participants continued to receive PVd or DPd until confirmed progressive disease (PD), death, intolerable toxicity, withdrawal of consent, or end of study, whichever occurred earlier.
|
Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel])
Participants received at least one cycle of bridging therapy, that is PVd: pomalidomide 4 mg PO on Days 1 to 14, bortezomib 1.3 mg/m\^2 SC injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg (or 10 mg for participants aged \>75 years) PO on Days 1, 2, 4, 5, 8, 9, 11, and 12; each treatment cycle of 21 days. DPd: daratumumab SC 1800 mg (co-formulated with rHuPH20) weekly on Days 1, 8, 15, and 22, pomalidomide 4 mg PO on Days 1 to 21, and dexamethasone PO or IV 40 mg (or 20 mg for participants aged \>75 years) weekly during Cycle 1-2 on Days 1, 8, 15, and 22 or split with 20 mg on Days 1, 2, 8, 9, 15, 16, 22, and 23. Each treatment cycle of 28 days. Additional cycles of bridging therapy was considered based on participant's clinical status and timing of availability of JNJ-68284528 (cilta-cel). Followed by bridging therapy, participants received conditioning regimen: cyclophosphamide 300 mg/m\^2 IV and fludarabine 30 mg/m\^2 IV daily, for 3 days on chimeric antigen receptor T cells (CAR-T) Day -5, -4, -3 (prior to JNJ-68284528 infusion), followed by JNJ-68284528 (cilta-cel) infusion 0.75\*10\^6 chimeric antigen receptor (CAR)-positive viable T cells per kilogram (kg) 5 to 7 days after the start of conditioning regimen.
|
|---|---|---|
|
Overall Study
Ongoing
|
124
|
157
|
|
Overall Study
Death
|
82
|
50
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
0
|
Baseline Characteristics
A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Arm A: Standard Therapy: PVd or DPd
n=211 Participants
Participants received either PVd or DPd as standard therapy. In pomalidomide, bortezomib and dexamethasone (PVd) treatment, participants received pomalidomide 4 milligrams (mg) orally (PO) on Days 1 to 14 in each treatment cycle; bortezomib 1.3 mg/meter square (m\^2) subcutaneous (SC) injection on Days 1, 4, 8 and 11 (Cycles 1 to 8) and on Days 1 and 8 (Cycle 9 onwards); and dexamethasone 20 mg (or 10 mg for participants aged greater than \[\>\] 75 years) PO on Days 1, 2, 4, 5, 8, 9, 11 and 12 (Cycles 1 to 8) and Days 1, 2, 8 and 9 (Cycle 9 onwards). Each treatment cycle of 21 days. In daratumumab, pomalidomide and dexamethasone (DPd) treatment, participants received daratumumab 1800 mg SC injection weekly on Days 1, 8, 15 and 22 (Cycle 1 and 2), every 2 weeks on Days 1 and 15 (Cycle 3 to 6) and every 4 weeks on Day 1 (Cycle 7 onwards); pomalidomide 4 mg PO on Days 1 to 21 (Cycle 1 onwards); dexamethasone 40 mg (or 20 mg for participants aged \>75 years) PO or intravenous(IV) weekly during Cycle 1-2 on Days 1, 8, 15, and 22 or split with 20 mg on Days 1, 2, 8, 9, 15, 16, 22, and 23. Each treatment cycle of 28 days. Participants continued to receive PVd or DPd until confirmed progressive disease (PD), death, intolerable toxicity, withdrawal of consent, or end of study, whichever occurred earlier.
|
Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel])
n=208 Participants
Participants received at least one cycle of bridging therapy, that is PVd: pomalidomide 4 mg PO on Days 1 to 14, bortezomib 1.3 mg/m\^2 SC injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg (or 10 mg for participants aged \>75 years) PO on Days 1, 2, 4, 5, 8, 9, 11, and 12; each treatment cycle of 21 days. DPd: daratumumab SC 1800 mg (co-formulated with rHuPH20) weekly on Days 1, 8, 15, and 22, pomalidomide 4 mg PO on Days 1 to 21, and dexamethasone PO or IV 40 mg (or 20 mg for participants aged \>75 years) weekly during Cycle 1-2 on Days 1, 8, 15, and 22 or split with 20 mg on Days 1, 2, 8, 9, 15, 16, 22, and 23. Each treatment cycle of 28 days. Additional cycles of bridging therapy was considered based on participant's clinical status and timing of availability of JNJ-68284528 (cilta-cel). Followed by bridging therapy, participants received conditioning regimen: cyclophosphamide 300 mg/m\^2 IV and fludarabine 30 mg/m\^2 IV daily, for 3 days on chimeric antigen receptor T cells (CAR-T) Day -5, -4, -3 (prior to JNJ-68284528 infusion), followed by JNJ-68284528 (cilta-cel) infusion 0.75\*10\^6 chimeric antigen receptor (CAR)-positive viable T cells per kilogram (kg) 5 to 7 days after the start of conditioning regimen.
|
Total
n=419 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.4 Years
STANDARD_DEVIATION 9.09 • n=10 Participants
|
59.7 Years
STANDARD_DEVIATION 10.09 • n=10 Participants
|
60.1 Years
STANDARD_DEVIATION 9.6 • n=20 Participants
|
|
Sex: Female, Male
Female
|
87 Participants
n=10 Participants
|
92 Participants
n=10 Participants
|
179 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
124 Participants
n=10 Participants
|
116 Participants
n=10 Participants
|
240 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=10 Participants
|
18 Participants
n=10 Participants
|
28 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
165 Participants
n=10 Participants
|
152 Participants
n=10 Participants
|
317 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
36 Participants
n=10 Participants
|
38 Participants
n=10 Participants
|
74 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
20 Participants
n=10 Participants
|
16 Participants
n=10 Participants
|
36 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=10 Participants
|
6 Participants
n=10 Participants
|
13 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
157 Participants
n=10 Participants
|
157 Participants
n=10 Participants
|
314 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
26 Participants
n=10 Participants
|
28 Participants
n=10 Participants
|
54 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: From randomization (Day 1) to either progressive disease or death, whichever occurred first (up to 3.9 years)Population: The intent-to-treat (ITT) analysis set included all participants who were randomized in the study.
PFS: defined as time from date of randomization to date of first documented progressed disease (PD) as per International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occurred first. PD: increase of 25% from lowest response value: serum and urine M-component (absolute increase must be \>=0.5 grams per deciliter \[g/dL\] and \>=200 milligrams \[mg\] per 24 hours, respectively); only in participants without measurable serum and urine M-protein levels, difference between involved and uninvolved free light chain (FLC) levels (absolute increase of \>10 mg/dL); only in participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow plasma cell (PC)% (absolute increase of \>=10%), appearance of new lesion; definite development of new bone lesions or definite increase in size of existing bone lesions, \>=50% increase in circulating PCs (minimum of 200 cells per microliter \[uL\]) if this was only measure of disease.
Outcome measures
| Measure |
Arm A: Standard Therapy: PVd or DPd
n=211 Participants
Participants received either PVd or DPd as standard therapy. In pomalidomide, bortezomib and dexamethasone (PVd) treatment, participants received pomalidomide 4 milligrams (mg) orally (PO) on Days 1 to 14 in each treatment cycle; bortezomib 1.3 mg/meter square (m\^2) subcutaneous (SC) injection on Days 1, 4, 8 and 11 (Cycles 1 to 8) and on Days 1 and 8 (Cycle 9 onwards); and dexamethasone 20 mg (or 10 mg for participants aged greater than \[\>\] 75 years) PO on Days 1, 2, 4, 5, 8, 9, 11 and 12 (Cycles 1 to 8) and Days 1, 2, 8 and 9 (Cycle 9 onwards). Each treatment cycle of 21 days. In daratumumab, pomalidomide and dexamethasone (DPd) treatment, participants received daratumumab 1800 mg SC injection weekly on Days 1, 8, 15 and 22 (Cycle 1 and 2), every 2 weeks on Days 1 and 15 (Cycle 3 to 6) and every 4 weeks on Day 1 (Cycle 7 onwards); pomalidomide 4 mg PO on Days 1 to 21 (Cycle 1 onwards); dexamethasone 40 mg (or 20 mg for participants aged \>75 years) PO or intravenous(IV) weekly during Cycle 1-2 on Days 1, 8, 15, and 22 or split with 20 mg on Days 1, 2, 8, 9, 15, 16, 22, and 23. Each treatment cycle of 28 days. Participants continued to receive PVd or DPd until confirmed progressive disease (PD), death, intolerable toxicity, withdrawal of consent, or end of study, whichever occurred earlier.
|
Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel])
n=208 Participants
Participants received at least one cycle of bridging therapy, that is PVd: pomalidomide 4 mg PO on Days 1 to 14, bortezomib 1.3 mg/m\^2 SC injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg (or 10 mg for participants aged \>75 years) PO on Days 1, 2, 4, 5, 8, 9, 11, and 12; each treatment cycle of 21 days. DPd: daratumumab SC 1800 mg (co-formulated with rHuPH20) weekly on Days 1, 8, 15, and 22, pomalidomide 4 mg PO on Days 1 to 21, and dexamethasone PO or IV 40 mg (or 20 mg for participants aged \>75 years) weekly during Cycle 1-2 on Days 1, 8, 15, and 22 or split with 20 mg on Days 1, 2, 8, 9, 15, 16, 22, and 23. Each treatment cycle of 28 days. Additional cycles of bridging therapy was considered based on participant's clinical status and timing of availability of JNJ-68284528 (cilta-cel). Followed by bridging therapy, participants received conditioning regimen: cyclophosphamide 300 mg/m\^2 IV and fludarabine 30 mg/m\^2 IV daily, for 3 days on chimeric antigen receptor T cells (CAR-T) Day -5, -4, -3 (prior to JNJ-68284528 infusion), followed by JNJ-68284528 (cilta-cel) infusion 0.75\*10\^6 chimeric antigen receptor (CAR)-positive viable T cells per kilogram (kg) 5 to 7 days after the start of conditioning regimen.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
11.79 months
Interval 9.66 to 14.0
|
NA months
Interval 34.5 to
NA refers to data not estimable for median and upper limit of 95% confidence interval due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: From randomization (Day 1) up to 7 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization (Day 1) up to 7 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization (Day 1) up to 12 months +/- 3 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization (Day 1) up to 7 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization (Day 1) up to 7 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization (Day 1) up to 7 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization (Day 1) up to 7 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization (Day 1) up to 7 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Cycle 1 Day 1 up to 7 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Cycle 1 Day 1 up to 7 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline (Cycle 1 Day 1) up to 7 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline (Cycle 1 Day 1) up to 7 years (each cycle of 28 days)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline (Cycle 1 Day 1) up to 7 years (each cycle of 28 days)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Cycle 1 Day 1 up to 7 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline (Cycle 1 Day 1) up to 7 years (each cycle of 28 days)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline (Cycle 1 Day 1) up to 7 years (each cycle of 28 days)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline (Cycle 1 Day 1) up to 7 years (each cycle of 28 days)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline (Cycle 1 Day 1) up to 7 years (each cycle of 28 days)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization (Day 1) up to 7 yearsOutcome measures
Outcome data not reported
Adverse Events
Arm A: Standard Therapy: PVd or DPd
Serious events: 98 serious events
Other events: 207 other events
Deaths: 83 deaths
Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel])
Serious events: 98 serious events
Other events: 208 other events
Deaths: 50 deaths
Serious adverse events
| Measure |
Arm A: Standard Therapy: PVd or DPd
n=208 participants at risk
Participants received either PVd or DPd as standard therapy. In pomalidomide, bortezomib and dexamethasone (PVd) treatment, participants received pomalidomide 4 milligrams (mg) orally (PO) on Days 1 to 14 in each treatment cycle; bortezomib 1.3 mg/meter square (m\^2) subcutaneous (SC) injection on Days 1, 4, 8 and 11 (Cycles 1 to 8) and on Days 1 and 8 (Cycle 9 onwards); and dexamethasone 20 mg (or 10 mg for participants aged greater than \[\>\] 75 years) PO on Days 1, 2, 4, 5, 8, 9, 11 and 12 (Cycles 1 to 8) and Days 1, 2, 8 and 9 (Cycle 9 onwards). Each treatment cycle of 21 days. In daratumumab, pomalidomide and dexamethasone (DPd) treatment, participants received daratumumab 1800 mg SC injection weekly on Days 1, 8, 15 and 22 (Cycle 1 and 2), every 2 weeks on Days 1 and 15 (Cycle 3 to 6) and every 4 weeks on Day 1 (Cycle 7 onwards); pomalidomide 4 mg PO on Days 1 to 21 (Cycle 1 onwards); dexamethasone 40 mg (or 20 mg for participants aged \>75 years) PO or intravenous(IV) weekly during Cycle 1-2 on Days 1, 8, 15, and 22 or split with 20 mg on Days 1, 2, 8, 9, 15, 16, 22, and 23. Each treatment cycle of 28 days. Participants continued to receive PVd or DPd until confirmed progressive disease (PD), death, intolerable toxicity, withdrawal of consent, or end of study, whichever occurred earlier.
|
Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel])
n=208 participants at risk
Participants received at least one cycle of bridging therapy, that is PVd: pomalidomide 4 mg PO on Days 1 to 14, bortezomib 1.3 mg/m\^2 SC injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg (or 10 mg for participants aged \>75 years) PO on Days 1, 2, 4, 5, 8, 9, 11, and 12; each treatment cycle of 21 days. DPd: daratumumab SC 1800 mg (co-formulated with rHuPH20) weekly on Days 1, 8, 15, and 22, pomalidomide 4 mg PO on Days 1 to 21, and dexamethasone PO or IV 40 mg (or 20 mg for participants aged \>75 years) weekly during Cycle 1-2 on Days 1, 8, 15, and 22 or split with 20 mg on Days 1, 2, 8, 9, 15, 16, 22, and 23. Each treatment cycle of 28 days. Additional cycles of bridging therapy was considered based on participant's clinical status and timing of availability of JNJ-68284528 (cilta-cel). Followed by bridging therapy, participants received conditioning regimen: cyclophosphamide 300 mg/m\^2 IV and fludarabine 30 mg/m\^2 IV daily, for 3 days on chimeric antigen receptor T cells (CAR-T) Day -5, -4, -3 (prior to JNJ-68284528 infusion), followed by JNJ-68284528 (cilta-cel) infusion 0.75\*10\^6 chimeric antigen receptor (CAR)-positive viable T cells per kilogram (kg) 5 to 7 days after the start of conditioning regimen.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
1.9%
4/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Blood and lymphatic system disorders
Cytopenia
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
2.9%
6/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
2.4%
5/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Blood and lymphatic system disorders
Hyperviscosity Syndrome
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Blood and lymphatic system disorders
Immune Thrombocytopenia
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
1.9%
4/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Cardiac disorders
Angina Pectoris
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Cardiac disorders
Atrial Fibrillation
|
1.9%
4/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Cardiac disorders
Atrial Flutter
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Cardiac disorders
Atrioventricular Block Second Degree
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Cardiac disorders
Cardiac Failure
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Cardiac disorders
Left Ventricular Dysfunction
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Cardiac disorders
Myocardial Infarction
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Cardiac disorders
Palpitations
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Eye disorders
Diplopia
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
2.4%
5/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Gastrointestinal disorders
Gastric Haemorrhage
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Gastrointestinal disorders
Ileus
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
General disorders
Chest Discomfort
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
General disorders
Chills
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
General disorders
Fatigue
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
General disorders
General Physical Health Deterioration
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
1.4%
3/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
General disorders
Pyrexia
|
2.4%
5/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
1.9%
4/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Hepatobiliary disorders
Cholestasis
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Immune system disorders
Cytokine Release Syndrome
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
3.4%
7/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Anal Abscess
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Appendicitis
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Bacteraemia
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Bacterial Pericarditis
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Cellulitis
|
0.96%
2/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Covid-19
|
3.4%
7/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
2.9%
6/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Covid-19 Pneumonia
|
5.8%
12/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
5.8%
12/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Cytomegalovirus Chorioretinitis
|
0.96%
2/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Cytomegalovirus Colitis
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Cytomegalovirus Infection
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.96%
2/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Cytomegalovirus Infection Reactivation
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Device Related Sepsis
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Endophthalmitis
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Enterocolitis Viral
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Epiglottitis
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Escherichia Urinary Tract Infection
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Gastroenteritis Bacterial
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Gastroenteritis Escherichia Coli
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Gastroenteritis Salmonella
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Gastrointestinal Infection
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Haemophilus Sepsis
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Infection
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Jc Virus Infection
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Large Intestine Infection
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Leishmaniasis
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.96%
2/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Metapneumovirus Infection
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Metapneumovirus Pneumonia
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
1.4%
3/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Neutropenic Sepsis
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Parainfluenzae Virus Infection
|
1.9%
4/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Parvovirus B19 Infection
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Pneumocystis Jirovecii Pneumonia
|
2.4%
5/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Pneumonia
|
6.7%
14/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
3.8%
8/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Pneumonia Haemophilus
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Pneumonia Klebsiella
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Pneumonia Legionella
|
0.96%
2/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Pneumonia Parainfluenzae Viral
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Pneumonia Pneumococcal
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Pneumonia Pseudomonal
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Pneumonia Respiratory Syncytial Viral
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Pneumonia Staphylococcal
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Pneumonia Streptococcal
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Post Procedural Infection
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Progressive Multifocal Leukoencephalopathy
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Pseudomonal Sepsis
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Pyelonephritis Acute
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Respiratory Syncytial Virus Infection
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.96%
2/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.96%
2/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Respiratory Tract Infection Viral
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Rhinovirus Infection
|
1.4%
3/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Rotavirus Infection
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Sepsis
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.96%
2/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Septic Shock
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Sinusitis Bacterial
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Soft Tissue Infection
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Staphylococcal Bacteraemia
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Staphylococcal Infection
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.96%
2/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Staphylococcal Skin Infection
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
2.4%
5/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
1.9%
4/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Upper Respiratory Tract Infection Bacterial
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Urinary Tract Infection
|
0.96%
2/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Urosepsis
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Viral Uveitis
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Injury, poisoning and procedural complications
Subdural Haemorrhage
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Injury, poisoning and procedural complications
Tracheal Obstruction
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Investigations
Procalcitonin Increased
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Investigations
Troponin I Increased
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.96%
2/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
2.4%
5/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Metabolism and nutrition disorders
Hyperferritinaemia
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.96%
2/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.96%
2/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pathological Fracture
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Myeloid Leukaemia
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Epstein-Barr Virus Associated Lymphoma
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive Lobular Breast Carcinoma
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip Squamous Cell Carcinoma
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Adenocarcinoma
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Pleural Effusion
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic Syndrome
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
1.4%
3/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic Syndrome with Multilineage Dysplasia
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm of Appendix
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paraneoplastic Syndrome
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peripheral T-Cell Lymphoma Unspecified
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.96%
2/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cell Carcinoma
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Serous Cystadenocarcinoma Ovary
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma of Skin
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil Cancer
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Nervous system disorders
Facial Paralysis
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
4.3%
9/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Nervous system disorders
Facial Paresis
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Nervous system disorders
Iiird Nerve Paralysis
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Nervous system disorders
Immune Effector Cell-Associated Neurotoxicity Syndrome
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Nervous system disorders
Ischaemic Stroke
|
0.96%
2/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Nervous system disorders
Parkinsonism
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Nervous system disorders
Spinal Cord Compression
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Nervous system disorders
Subdural Hygroma
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Nervous system disorders
Syncope
|
0.96%
2/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Nervous system disorders
Trigeminal Palsy
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Psychiatric disorders
Confusional State
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Psychiatric disorders
Mental Disorder
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
1.4%
3/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.96%
2/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Renal and urinary disorders
Haematuria
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Reproductive system and breast disorders
Pelvic Pain
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Lung Disorder
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.96%
2/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.9%
4/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.96%
2/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.96%
2/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Vascular disorders
Hypertension
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Vascular disorders
Thrombophlebitis
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
Other adverse events
| Measure |
Arm A: Standard Therapy: PVd or DPd
n=208 participants at risk
Participants received either PVd or DPd as standard therapy. In pomalidomide, bortezomib and dexamethasone (PVd) treatment, participants received pomalidomide 4 milligrams (mg) orally (PO) on Days 1 to 14 in each treatment cycle; bortezomib 1.3 mg/meter square (m\^2) subcutaneous (SC) injection on Days 1, 4, 8 and 11 (Cycles 1 to 8) and on Days 1 and 8 (Cycle 9 onwards); and dexamethasone 20 mg (or 10 mg for participants aged greater than \[\>\] 75 years) PO on Days 1, 2, 4, 5, 8, 9, 11 and 12 (Cycles 1 to 8) and Days 1, 2, 8 and 9 (Cycle 9 onwards). Each treatment cycle of 21 days. In daratumumab, pomalidomide and dexamethasone (DPd) treatment, participants received daratumumab 1800 mg SC injection weekly on Days 1, 8, 15 and 22 (Cycle 1 and 2), every 2 weeks on Days 1 and 15 (Cycle 3 to 6) and every 4 weeks on Day 1 (Cycle 7 onwards); pomalidomide 4 mg PO on Days 1 to 21 (Cycle 1 onwards); dexamethasone 40 mg (or 20 mg for participants aged \>75 years) PO or intravenous(IV) weekly during Cycle 1-2 on Days 1, 8, 15, and 22 or split with 20 mg on Days 1, 2, 8, 9, 15, 16, 22, and 23. Each treatment cycle of 28 days. Participants continued to receive PVd or DPd until confirmed progressive disease (PD), death, intolerable toxicity, withdrawal of consent, or end of study, whichever occurred earlier.
|
Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel])
n=208 participants at risk
Participants received at least one cycle of bridging therapy, that is PVd: pomalidomide 4 mg PO on Days 1 to 14, bortezomib 1.3 mg/m\^2 SC injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg (or 10 mg for participants aged \>75 years) PO on Days 1, 2, 4, 5, 8, 9, 11, and 12; each treatment cycle of 21 days. DPd: daratumumab SC 1800 mg (co-formulated with rHuPH20) weekly on Days 1, 8, 15, and 22, pomalidomide 4 mg PO on Days 1 to 21, and dexamethasone PO or IV 40 mg (or 20 mg for participants aged \>75 years) weekly during Cycle 1-2 on Days 1, 8, 15, and 22 or split with 20 mg on Days 1, 2, 8, 9, 15, 16, 22, and 23. Each treatment cycle of 28 days. Additional cycles of bridging therapy was considered based on participant's clinical status and timing of availability of JNJ-68284528 (cilta-cel). Followed by bridging therapy, participants received conditioning regimen: cyclophosphamide 300 mg/m\^2 IV and fludarabine 30 mg/m\^2 IV daily, for 3 days on chimeric antigen receptor T cells (CAR-T) Day -5, -4, -3 (prior to JNJ-68284528 infusion), followed by JNJ-68284528 (cilta-cel) infusion 0.75\*10\^6 chimeric antigen receptor (CAR)-positive viable T cells per kilogram (kg) 5 to 7 days after the start of conditioning regimen.
|
|---|---|---|
|
Eye disorders
Cataract
|
7.2%
15/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
0.48%
1/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Eye disorders
Vision Blurred
|
5.8%
12/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
1.9%
4/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Gastrointestinal disorders
Abdominal Pain
|
7.7%
16/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
4.8%
10/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
22.6%
47/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
23.6%
49/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
31.2%
65/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
33.2%
69/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
20.7%
43/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
48.6%
101/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
8.7%
18/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
13.9%
29/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
General disorders
Asthenia
|
16.3%
34/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
17.3%
36/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
General disorders
Chills
|
3.8%
8/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
6.2%
13/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
General disorders
Fatigue
|
33.7%
70/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
28.8%
60/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
General disorders
Oedema Peripheral
|
13.5%
28/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
16.8%
35/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
General disorders
Pyrexia
|
14.9%
31/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
14.9%
31/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Immune system disorders
Cytokine Release Syndrome
|
0.00%
0/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
62.0%
129/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
8.7%
18/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
45.2%
94/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Bronchitis
|
10.1%
21/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
1.9%
4/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Covid-19
|
29.3%
61/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
7.7%
16/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
10.1%
21/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
5.8%
12/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Pneumonia
|
5.8%
12/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
3.8%
8/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Respiratory Tract Infection
|
8.2%
17/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
7.7%
16/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
24.5%
51/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
10.1%
21/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Infections and infestations
Urinary Tract Infection
|
6.7%
14/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
4.8%
10/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
5.8%
12/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
4.3%
9/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Investigations
Alanine Aminotransferase Increased
|
7.2%
15/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
8.2%
17/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Investigations
Aspartate Aminotransferase Increased
|
3.4%
7/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
5.3%
11/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
27.4%
57/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
52.9%
110/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
7.7%
16/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
13.0%
27/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
13.9%
29/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
22.6%
47/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
85.6%
178/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
89.9%
187/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
32.2%
67/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
54.3%
113/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
1.9%
4/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
5.3%
11/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
1.4%
3/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
6.7%
14/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
6.2%
13/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
16.3%
34/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
2.9%
6/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
6.2%
13/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.2%
13/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
4.8%
10/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.1%
19/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
18.8%
39/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
4.8%
10/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
9.6%
20/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
4.3%
9/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
9.6%
20/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.3%
34/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
15.4%
32/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
22.1%
46/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
14.9%
31/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
11.1%
23/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
10.1%
21/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
14.9%
31/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
10.1%
21/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
6.7%
14/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
3.8%
8/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
10.6%
22/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
6.2%
13/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.3%
11/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
6.7%
14/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
7.7%
16/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
8.2%
17/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Nervous system disorders
Dizziness
|
14.4%
30/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
11.5%
24/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Nervous system disorders
Headache
|
13.0%
27/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
26.4%
55/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Nervous system disorders
Paraesthesia
|
4.8%
10/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
5.8%
12/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
20.7%
43/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
15.9%
33/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Nervous system disorders
Tremor
|
10.6%
22/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
6.7%
14/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Psychiatric disorders
Anxiety
|
6.2%
13/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
4.3%
9/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Psychiatric disorders
Insomnia
|
26.4%
55/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
11.1%
23/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.3%
38/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
13.9%
29/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.7%
43/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
13.5%
28/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.8%
12/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
2.9%
6/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
5.3%
11/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
4.3%
9/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
5.3%
11/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
3.4%
7/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.3%
11/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
9.1%
19/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.3%
11/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
10.6%
22/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Vascular disorders
Hypertension
|
10.1%
21/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
7.2%
15/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
|
Vascular disorders
Hypotension
|
0.96%
2/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
8.2%
17/208 • All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
|
Additional Information
Executive Medical Director Oncology
Janssen Research & Development, LLC
Phone: 844-434-4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
- Publication restrictions are in place
Restriction type: OTHER