Trial Outcomes & Findings for A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma (NCT NCT03301220)
NCT ID: NCT03301220
Last Updated: 2026-04-13
Results Overview
PFS was defined as the duration from the date of randomization to either progressive to multiple myeloma (MM), according to the International Myeloma Working Group (IMWG) diagnostic criteria for MM, or death due to any cause, whichever occurred first. Per IMWG criteria, active MM by SLiM-CRAB defined as: greater than or equal to (\>=) 60 percent (%) bone marrow plasma cells (BMPCs), free light chain (FLC) involved/uninvolved ratio \>=100, greater than (\>)1 focal bone lesions on magnetic resonance imaging (MRI), calcium elevation, renal insufficiency by creatinine clearance, anemia, or bone disease due to lytic bone lesions. Kaplan-Meier estimate was used.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
390 participants
Primary outcome timeframe
From randomization (Day -5) up to 77 months
Results posted on
2026-04-13
Participant Flow
Results are currently reported until the primary completion date (01 May 2024). Results of remaining duration will be posted upon study completion.
Participant milestones
| Measure |
Arm A: Active Monitoring (ACTM)
Participants in the active monitoring group did not receive any study medication but underwent disease evaluations for every 12 weeks until disease progression (PD) as those randomized to receive daratumumab.
|
Arm B: Daratumumab SC
Participants received daratumumab 1800 milligrams (mg) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 units per milliliter (U/mL) as subcutaneous (SC) injection once every week (Q1W) (Days 1, 8, 15, and 22 of each week) in Cycles 1 and 2, every 2 weeks (Q2W) (Days 1 and 15) from Cycle 3 to Cycle 6, and thereafter every 4 weeks (Day 1) from Cycle 7 to Cycle 39, for a maximum of 36 months, or until confirmed disease progression, unacceptable toxicity or withdrawal from the study treatment. In addition, disease evaluations were performed every 12 weeks until PD. Each treatment cycle was 28 days. After end of treatment, participants were followed up for safety until death, lost to follow up, consent withdrawal or study end, whichever occurred first (up to 8 years).
|
|---|---|---|
|
Overall Study
STARTED
|
196
|
194
|
|
Overall Study
Treated
|
196
|
193
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
196
|
194
|
Reasons for withdrawal
| Measure |
Arm A: Active Monitoring (ACTM)
Participants in the active monitoring group did not receive any study medication but underwent disease evaluations for every 12 weeks until disease progression (PD) as those randomized to receive daratumumab.
|
Arm B: Daratumumab SC
Participants received daratumumab 1800 milligrams (mg) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 units per milliliter (U/mL) as subcutaneous (SC) injection once every week (Q1W) (Days 1, 8, 15, and 22 of each week) in Cycles 1 and 2, every 2 weeks (Q2W) (Days 1 and 15) from Cycle 3 to Cycle 6, and thereafter every 4 weeks (Day 1) from Cycle 7 to Cycle 39, for a maximum of 36 months, or until confirmed disease progression, unacceptable toxicity or withdrawal from the study treatment. In addition, disease evaluations were performed every 12 weeks until PD. Each treatment cycle was 28 days. After end of treatment, participants were followed up for safety until death, lost to follow up, consent withdrawal or study end, whichever occurred first (up to 8 years).
|
|---|---|---|
|
Overall Study
Death
|
26
|
15
|
|
Overall Study
Withdrawal by Subject
|
23
|
12
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Randomized in error
|
1
|
1
|
|
Overall Study
Randomized but not treated
|
0
|
1
|
|
Overall Study
Ongoing followup
|
145
|
163
|
|
Overall Study
Principal Investigator and participant decision
|
0
|
1
|
Baseline Characteristics
A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Arm A: Active Monitoring (ACTM)
n=196 Participants
Participants in the active monitoring group did not receive any study medication but underwent disease evaluations for every 12 weeks until disease progression (PD) as those randomized to receive daratumumab.
|
Arm B: Daratumumab SC
n=194 Participants
Participants received daratumumab 1800 milligrams (mg) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 units per milliliter (U/mL) as subcutaneous (SC) injection once every week (Q1W) (Days 1, 8, 15, and 22 of each week) in Cycles 1 and 2, every 2 weeks (Q2W) (Days 1 and 15) from Cycle 3 to Cycle 6, and thereafter every 4 weeks (Day 1) from Cycle 7 to Cycle 39, for a maximum of 36 months, or until confirmed disease progression, unacceptable toxicity or withdrawal from the study treatment. In addition, disease evaluations were performed every 12 weeks until PD. Each treatment cycle was 28 days. After end of treatment, participants were followed up for safety until death, lost to follow up, consent withdrawal or study end, whichever occurred first (up to 8 years).
|
Total
n=390 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.0 Years
STANDARD_DEVIATION 10.76 • n=193 Participants
|
61.9 Years
STANDARD_DEVIATION 11.17 • n=193 Participants
|
62.4 Years
STANDARD_DEVIATION 10.97 • n=386 Participants
|
|
Sex: Female, Male
Female
|
103 Participants
n=193 Participants
|
99 Participants
n=193 Participants
|
202 Participants
n=386 Participants
|
|
Sex: Female, Male
Male
|
93 Participants
n=193 Participants
|
95 Participants
n=193 Participants
|
188 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=193 Participants
|
14 Participants
n=193 Participants
|
23 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
176 Participants
n=193 Participants
|
169 Participants
n=193 Participants
|
345 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=193 Participants
|
11 Participants
n=193 Participants
|
22 Participants
n=386 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
3 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=193 Participants
|
18 Participants
n=193 Participants
|
31 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
2 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=193 Participants
|
4 Participants
n=193 Participants
|
11 Participants
n=386 Participants
|
|
Race (NIH/OMB)
White
|
162 Participants
n=193 Participants
|
161 Participants
n=193 Participants
|
323 Participants
n=386 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
1 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=193 Participants
|
10 Participants
n=193 Participants
|
19 Participants
n=386 Participants
|
|
Region of Enrollment
Belgium
|
6 Participants
n=193 Participants
|
4 Participants
n=193 Participants
|
10 Participants
n=386 Participants
|
|
Region of Enrollment
France
|
9 Participants
n=193 Participants
|
7 Participants
n=193 Participants
|
16 Participants
n=386 Participants
|
|
Region of Enrollment
Germany
|
4 Participants
n=193 Participants
|
4 Participants
n=193 Participants
|
8 Participants
n=386 Participants
|
|
Region of Enrollment
Netherlands
|
6 Participants
n=193 Participants
|
3 Participants
n=193 Participants
|
9 Participants
n=386 Participants
|
|
Region of Enrollment
United States
|
27 Participants
n=193 Participants
|
30 Participants
n=193 Participants
|
57 Participants
n=386 Participants
|
|
Region of Enrollment
Argentina
|
5 Participants
n=193 Participants
|
4 Participants
n=193 Participants
|
9 Participants
n=386 Participants
|
|
Region of Enrollment
Australia
|
10 Participants
n=193 Participants
|
5 Participants
n=193 Participants
|
15 Participants
n=386 Participants
|
|
Region of Enrollment
Brazil
|
3 Participants
n=193 Participants
|
8 Participants
n=193 Participants
|
11 Participants
n=386 Participants
|
|
Region of Enrollment
Canada
|
6 Participants
n=193 Participants
|
2 Participants
n=193 Participants
|
8 Participants
n=386 Participants
|
|
Region of Enrollment
Czech Republic
|
2 Participants
n=193 Participants
|
6 Participants
n=193 Participants
|
8 Participants
n=386 Participants
|
|
Region of Enrollment
Denmark
|
0 Participants
n=193 Participants
|
2 Participants
n=193 Participants
|
2 Participants
n=386 Participants
|
|
Region of Enrollment
Greece
|
3 Participants
n=193 Participants
|
8 Participants
n=193 Participants
|
11 Participants
n=386 Participants
|
|
Region of Enrollment
Hungary
|
8 Participants
n=193 Participants
|
4 Participants
n=193 Participants
|
12 Participants
n=386 Participants
|
|
Region of Enrollment
Israel
|
28 Participants
n=193 Participants
|
28 Participants
n=193 Participants
|
56 Participants
n=386 Participants
|
|
Region of Enrollment
Italy
|
4 Participants
n=193 Participants
|
8 Participants
n=193 Participants
|
12 Participants
n=386 Participants
|
|
Region of Enrollment
Japan
|
13 Participants
n=193 Participants
|
15 Participants
n=193 Participants
|
28 Participants
n=386 Participants
|
|
Region of Enrollment
Norway
|
8 Participants
n=193 Participants
|
7 Participants
n=193 Participants
|
15 Participants
n=386 Participants
|
|
Region of Enrollment
Poland
|
6 Participants
n=193 Participants
|
6 Participants
n=193 Participants
|
12 Participants
n=386 Participants
|
|
Region of Enrollment
Russian Federation
|
9 Participants
n=193 Participants
|
4 Participants
n=193 Participants
|
13 Participants
n=386 Participants
|
|
Region of Enrollment
Spain
|
14 Participants
n=193 Participants
|
10 Participants
n=193 Participants
|
24 Participants
n=386 Participants
|
|
Region of Enrollment
Sweden
|
3 Participants
n=193 Participants
|
2 Participants
n=193 Participants
|
5 Participants
n=386 Participants
|
|
Region of Enrollment
Turkey
|
5 Participants
n=193 Participants
|
9 Participants
n=193 Participants
|
14 Participants
n=386 Participants
|
|
Region of Enrollment
United Kingdom
|
17 Participants
n=193 Participants
|
18 Participants
n=193 Participants
|
35 Participants
n=386 Participants
|
PRIMARY outcome
Timeframe: From randomization (Day -5) up to 77 monthsPopulation: Intent-to-treat (ITT) analysis set included all participants randomized into the study.
PFS was defined as the duration from the date of randomization to either progressive to multiple myeloma (MM), according to the International Myeloma Working Group (IMWG) diagnostic criteria for MM, or death due to any cause, whichever occurred first. Per IMWG criteria, active MM by SLiM-CRAB defined as: greater than or equal to (\>=) 60 percent (%) bone marrow plasma cells (BMPCs), free light chain (FLC) involved/uninvolved ratio \>=100, greater than (\>)1 focal bone lesions on magnetic resonance imaging (MRI), calcium elevation, renal insufficiency by creatinine clearance, anemia, or bone disease due to lytic bone lesions. Kaplan-Meier estimate was used.
Outcome measures
| Measure |
Arm A: Active Monitoring (ACTM)
n=196 Participants
Participants in the active monitoring group did not receive any study medication but underwent disease evaluations for every 12 weeks until disease progression (PD) as those randomized to receive daratumumab.
|
Arm B: Daratumumab SC
n=194 Participants
Participants received daratumumab 1800 milligrams (mg) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 units per milliliter (U/mL) as subcutaneous (SC) injection once every week (Q1W) (Days 1, 8, 15, and 22 of each week) in Cycles 1 and 2, every 2 weeks (Q2W) (Days 1 and 15) from Cycle 3 to Cycle 6, and thereafter every 4 weeks (Day 1) from Cycle 7 to Cycle 39, for a maximum of 36 months, or until confirmed disease progression, unacceptable toxicity or withdrawal from the study treatment. In addition, disease evaluations were performed every 12 weeks until PD. Each treatment cycle was 28 days. After end of treatment, participants were followed up for safety until death, lost to follow up, consent withdrawal or study end, whichever occurred first (up to 8 years).
|
|---|---|---|
|
Progression-Free Survival (PFS) as Assessed by the Independent Review Committee (IRC)
|
41.46 Months
Interval 26.41 to 53.32
|
NA Months
Interval 66.69 to
Here "NA" signifies that median and upper limit of 95% confidence interval (CI) were not estimable due to low number of participants with events.
|
SECONDARY outcome
Timeframe: From randomization (Day -5) up to 8 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization (Day -5) up to 8 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization (Day -5) up to 8 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization (Day -5) up to 8 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization (Day -5) up to 8 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization (Day -5) up to 8 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization (Day -5) up to 8 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization (Day -5) up to 8 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycles 1 and 3 : Day 1 predose, and Day 4 postdose; Cycles 5, 7, 12, and 24: Day 1 predose; end of the treatment (EOT, 37.11 months); and 8 weeks after the last daratumumab dose (up to 38.11 months). Each Cycle was 28 daysOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycles 1 and 3 : Day 1 predose, and Day 4 postdose; Cycles 5, 7, 12, and 24: Day 1 predose; EOT( 37.11 months); and 8 weeks after the last daratumumab dose (up to 38.11 months). Each Cycle was 28 daysOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycles 1 and 3 : Day 1 predose, and Day 4 postdose; Cycles 5, 7, 12, and 24: Day 1 predose; EOT (37.11 months); and 8 weeks after the last daratumumab dose (up to 38.11 months). Each Cycle was 28 daysOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycles 1, 3, 5, 7, 12, and 24 : Predose on Day 1; EOT (37.11 months); and 8 weeks after the last daratumumab dose (up to 38.11 months). Each Cycle was 28 daysOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Baseline (Day -35) up to 8 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Baseline (Day -35) up to 8 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Baseline (Day -35) up to 8 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization (Day -5) up to 8 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization (Day -5) up to 8 yearsOutcome measures
Outcome data not reported
Adverse Events
Arm A: Active Monitoring (ACTM)
Serious events: 38 serious events
Other events: 140 other events
Deaths: 26 deaths
Arm B: Daratumumab SC
Serious events: 56 serious events
Other events: 178 other events
Deaths: 15 deaths
Serious adverse events
| Measure |
Arm A: Active Monitoring (ACTM)
n=196 participants at risk
Participants in the active monitoring group did not receive any study medication but underwent disease evaluations for every 12 weeks until disease progression (PD) as those randomized to receive daratumumab.
|
Arm B: Daratumumab SC
n=193 participants at risk
Participants received daratumumab 1800 milligrams (mg) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 units per milliliter (U/mL) as subcutaneous (SC) injection once every week (Q1W) (Days 1, 8, 15, and 22 of each week) in Cycles 1 and 2, every 2 weeks (Q2W) (Days 1 and 15) from Cycle 3 to Cycle 6, and thereafter every 4 weeks (Day 1) from Cycle 7 to Cycle 39, for a maximum of 36 months, or until confirmed disease progression, unacceptable toxicity or withdrawal from the study treatment. In addition, disease evaluations were performed every 12 weeks until PD. Each treatment cycle was 28 days. After end of treatment, participants were followed up for safety until death, lost to follow up, consent withdrawal or study end, whichever occurred first (up to 8 years).
|
|---|---|---|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Cardiac disorders
Angina Pectoris
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Cardiac disorders
Cardiac Arrest
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.00%
0/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Cardiac disorders
Cardiac Failure
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.00%
0/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Cardiac disorders
Myocardial Ischaemia
|
1.0%
2/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.00%
0/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Cardiac disorders
Sinus Tachycardia
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.00%
0/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Ear and labyrinth disorders
Vertigo Positional
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Eye disorders
Cataract
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Eye disorders
Glaucoma
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.00%
0/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Eye disorders
Lacrimation Increased
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.00%
0/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
1.0%
2/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Gastrointestinal disorders
Haemorrhoidal Haemorrhage
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.00%
0/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
1.0%
2/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Gastrointestinal disorders
Obstruction Gastric
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.00%
0/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
1.0%
2/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Gastrointestinal disorders
Volvulus
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
General disorders
Chest Pain
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.00%
0/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
General disorders
Gait Disturbance
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
1.0%
2/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
General disorders
Pain
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.00%
0/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
General disorders
Pelvic Mass
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.00%
0/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
General disorders
Pyrexia
|
1.0%
2/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Hepatobiliary disorders
Cholecystitis
|
1.0%
2/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.00%
0/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Infections and infestations
Appendicitis
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.00%
0/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Infections and infestations
Bacteraemia
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.00%
0/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
1.0%
2/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Infections and infestations
Corneal Infection
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Infections and infestations
Covid-19
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
1.6%
3/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Infections and infestations
Covid-19 Pneumonia
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
1.0%
2/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Infections and infestations
Diverticulitis
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Infections and infestations
Gastroenteritis Norovirus
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Infections and infestations
Metapneumovirus Infection
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Infections and infestations
Pneumonia
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
3.6%
7/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Infections and infestations
Pneumonia Bacterial
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Infections and infestations
Pneumonia Pneumococcal
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.00%
0/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Infections and infestations
Pneumonia Streptococcal
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Infections and infestations
Pneumonia Viral
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
1.0%
2/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Infections and infestations
Sepsis
|
1.0%
2/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
1.0%
2/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Infections and infestations
Septic Arthritis Staphylococcal
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Infections and infestations
Septic Shock
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Infections and infestations
Urinary Tract Infection
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Infections and infestations
Vestibular Neuronitis
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.00%
0/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Infections and infestations
West Nile Viral Infection
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.00%
0/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Injury, poisoning and procedural complications
Incisional Hernia
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
1.0%
2/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Injury, poisoning and procedural complications
Shoulder Fracture
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
1.0%
2/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Injury, poisoning and procedural complications
Splenic Injury
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.00%
0/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Injury, poisoning and procedural complications
Traumatic Fracture
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.00%
0/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.00%
0/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive Ductal Breast Carcinoma
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.00%
0/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm of Appendix
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.00%
0/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmacytoma
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.00%
0/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Nervous system disorders
Brain Oedema
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Nervous system disorders
Cerebellar Stroke
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.00%
0/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Nervous system disorders
Cerebral Ischaemia
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.00%
0/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Nervous system disorders
Dizziness
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.00%
0/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Nervous system disorders
Intracranial Aneurysm
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Nervous system disorders
Ischaemic Stroke
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.00%
0/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.00%
0/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
1.0%
2/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.00%
0/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Renal and urinary disorders
Haematuria
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.00%
0/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Renal and urinary disorders
Renal Injury
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.00%
0/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.00%
0/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Reproductive system and breast disorders
Pelvic Organ Prolapse
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.00%
0/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.00%
0/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
1.0%
2/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Respiratory, thoracic and mediastinal disorders
Organising Pneumonia
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.00%
0/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.00%
0/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.00%
0/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Skin and subcutaneous tissue disorders
Dermal Cyst
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Skin and subcutaneous tissue disorders
Diabetic Foot
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Surgical and medical procedures
Breast Prosthesis Removal
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Surgical and medical procedures
Radical Prostatectomy
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
0.52%
1/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
Other adverse events
| Measure |
Arm A: Active Monitoring (ACTM)
n=196 participants at risk
Participants in the active monitoring group did not receive any study medication but underwent disease evaluations for every 12 weeks until disease progression (PD) as those randomized to receive daratumumab.
|
Arm B: Daratumumab SC
n=193 participants at risk
Participants received daratumumab 1800 milligrams (mg) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 units per milliliter (U/mL) as subcutaneous (SC) injection once every week (Q1W) (Days 1, 8, 15, and 22 of each week) in Cycles 1 and 2, every 2 weeks (Q2W) (Days 1 and 15) from Cycle 3 to Cycle 6, and thereafter every 4 weeks (Day 1) from Cycle 7 to Cycle 39, for a maximum of 36 months, or until confirmed disease progression, unacceptable toxicity or withdrawal from the study treatment. In addition, disease evaluations were performed every 12 weeks until PD. Each treatment cycle was 28 days. After end of treatment, participants were followed up for safety until death, lost to follow up, consent withdrawal or study end, whichever occurred first (up to 8 years).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
9.7%
19/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
4.7%
9/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.6%
5/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
6.7%
13/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Cardiac disorders
Palpitations
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
6.7%
13/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Eye disorders
Cataract
|
3.1%
6/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
5.2%
10/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Gastrointestinal disorders
Abdominal Pain
|
6.1%
12/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
9.3%
18/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
6.2%
12/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Gastrointestinal disorders
Constipation
|
4.1%
8/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
9.3%
18/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.6%
9/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
26.4%
51/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.0%
2/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
5.2%
10/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
1.0%
2/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
6.2%
12/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Gastrointestinal disorders
Nausea
|
4.6%
9/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
19.2%
37/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Gastrointestinal disorders
Vomiting
|
3.6%
7/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
8.3%
16/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
General disorders
Asthenia
|
7.7%
15/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
9.3%
18/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
General disorders
Chest Discomfort
|
1.0%
2/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
5.2%
10/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
General disorders
Fatigue
|
13.3%
26/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
34.2%
66/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
General disorders
Influenza Like Illness
|
3.6%
7/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
8.8%
17/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
General disorders
Injection Site Erythema
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
16.1%
31/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
General disorders
Oedema Peripheral
|
1.5%
3/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
10.4%
20/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
General disorders
Pyrexia
|
2.0%
4/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
17.1%
33/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Infections and infestations
Bronchitis
|
2.6%
5/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
6.7%
13/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Infections and infestations
Covid-19
|
5.1%
10/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
7.8%
15/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Infections and infestations
Influenza
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
5.2%
10/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Infections and infestations
Nasopharyngitis
|
11.7%
23/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
25.4%
49/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Infections and infestations
Pneumonia
|
4.6%
9/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
8.8%
17/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Infections and infestations
Sinusitis
|
2.6%
5/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
8.8%
17/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
7.7%
15/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
30.1%
58/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Infections and infestations
Urinary Tract Infection
|
5.1%
10/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
6.2%
12/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Injury, poisoning and procedural complications
Contusion
|
1.5%
3/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
5.2%
10/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Injury, poisoning and procedural complications
Fall
|
6.1%
12/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
5.2%
10/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.9%
35/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
26.9%
52/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
19.4%
38/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
23.8%
46/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
6.2%
12/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.6%
9/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
10.4%
20/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
7.7%
15/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
14.5%
28/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Nervous system disorders
Dizziness
|
4.1%
8/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
9.8%
19/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Nervous system disorders
Headache
|
6.6%
13/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
18.1%
35/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Nervous system disorders
Paraesthesia
|
4.1%
8/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
8.8%
17/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
1.5%
3/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
8.3%
16/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Psychiatric disorders
Anxiety
|
3.6%
7/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
7.3%
14/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Psychiatric disorders
Insomnia
|
2.6%
5/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
22.3%
43/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.1%
12/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
17.1%
33/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.1%
10/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
15.0%
29/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
1.5%
3/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
9.3%
18/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
1.5%
3/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
8.3%
16/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.0%
2/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
5.7%
11/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
5.2%
10/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
8.8%
17/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
8.8%
17/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.51%
1/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
8.3%
16/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Vascular disorders
Flushing
|
0.00%
0/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
5.2%
10/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
|
Vascular disorders
Hypertension
|
9.7%
19/196 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
10.4%
20/193 • All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
|
Additional Information
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