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NCT03301220 · ADVERSE EVENTS

Adverse events

A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma · Source last updated 2026-06-08

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)
Other-event reporting threshold
5%

All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
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.

38 / 196140 / 19626 / 196
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).

56 / 193178 / 19315 / 194

Group identifiers: EG000: Arm A: Active Monitoring (ACTM) · EG001: Arm B: Daratumumab SC

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      196
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      193
    term
    Iron Deficiency Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      196
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      193
    term
    Angina Pectoris
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      196
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      193
    term
    Atrial Fibrillation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      196
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      193
    term
    Cardiac Arrest
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      196
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      193
    term
    Cardiac Failure
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      196
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      193
    term
    Myocardial Ischaemia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      196
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      193
    term
    Sinus Tachycardia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      196
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      193
    term
    Hypoacusis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      196
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      193
    term
    Vertigo Positional
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      196
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      193
    term
    Cataract
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      196
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      193
    term
    Glaucoma
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      196
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      193
    term
    Lacrimation Increased

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      196
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      193
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      196
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      193
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      196
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      193
    term
    Palpitations
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      196
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      193
    term
    Cataract
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      196
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      193
    term
    Abdominal Pain
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      196
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      193
    term
    Abdominal Pain Upper
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      196
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      193
    term
    Constipation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      196
    2. group Id
      EG001
      num Affected
      51
      num At Risk
      193
    term
    Diarrhoea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      196
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      193
    term
    Dyspepsia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      196
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      193
    term
    Gastrooesophageal Reflux Disease
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      196
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      193
    term
    Nausea
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      196
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      193
    term
    Vomiting
Complete source fields
description
All Cause Mortality: all participants randomized into the study; SAEs and Other AEs: Safety analysis set included all randomized participants for participants randomized to active monitoring or all randomized participants who received at least one dose of daratumumab for participants randomized to daratumumab.
event Groups
  1. deaths Num Affected
    26
    deaths Num At Risk
    196
    description
    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.
    id
    EG000
    other Num Affected
    140
    other Num At Risk
    196
    serious Num Affected
    38
    serious Num At Risk
    196
    title
    Arm A: Active Monitoring (ACTM)
  2. deaths Num Affected
    15
    deaths Num At Risk
    194
    description
    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).
    id
    EG001
    other Num Affected
    178
    other Num At Risk
    193
    serious Num Affected
    56
    serious Num At Risk
    193
    title
    Arm B: Daratumumab SC
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      196
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      193
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      196
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      193
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      196
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      193
    term
    Palpitations
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      196
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      193
    term
    Cataract
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      196
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      193
    term
    Abdominal Pain
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      196
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      193
    term
    Abdominal Pain Upper
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      196
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      193
    term
    Constipation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      196
    2. group Id
      EG001
      num Affected
      51
      num At Risk
      193
    term
    Diarrhoea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      196
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      193
    term
    Dyspepsia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      196
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      193
    term
    Gastrooesophageal Reflux Disease
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      196
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      193
    term
    Nausea
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      196
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      193
    term
    Vomiting
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      196
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      193
    term
    Iron Deficiency Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      196
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      193
    term
    Angina Pectoris
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      196
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      193
    term
    Atrial Fibrillation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      196
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      193
    term
    Cardiac Arrest
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      196
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      193
    term
    Cardiac Failure
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      196
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      193
    term
    Myocardial Ischaemia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      196
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      193
    term
    Sinus Tachycardia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      196
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      193
    term
    Hypoacusis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      196
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      193
    term
    Vertigo Positional
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      196
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      193
    term
    Cataract
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      196
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      193
    term
    Glaucoma
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      196
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      193
    term
    Lacrimation Increased
time Frame
All-cause mortality: From randomization (Day -5) up to 77 months, Serious adverse events (SAE) and other adverse events (AEs): active monitoring Arm : From start of treatment (Cycle 1 Day 1) up to 37 months; daratumumab SC arm: From start of treatment (Cycle 1 Day 1) up to 30 days after the last dose of study treatment (up to 37.11 months)

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