Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01615029 · ADVERSE EVENTS

Adverse events

Daratumumab in Combination With Lenalidomide and Dexamethasone in Relapsed and Relapsed-refractory Multiple Myeloma · Source last updated 2026-03-16

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
Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
Other-event reporting threshold
5%

All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone

Participants received daratumumab 2 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (cycles 3 to 6), Day 1 (cycle 7+) along with lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.

2 / 33 / 30 / 3
Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone

Participants administered with daratumumab 4 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.

2 / 33 / 30 / 3
Phase 1: 8mg/kg Daratumumab + Lenalidomide and Dexamethasone

Participants received with daratumumab 8 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (cycles 3 to 6), Day 1 (cycle 7+) along with lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.

3 / 44 / 41 / 4
Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone

Participants administered with daratumumab 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.

2 / 33 / 30 / 3
Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone

Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.

22 / 3231 / 321 / 32

Group identifiers: EG000: Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone · EG001: Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone · EG002: Phase 1: 8mg/kg Daratumumab + Lenalidomide and Dexamethasone · EG003: Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone · EG004: Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone

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 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      32
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      32
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      32
    term
    Atrial Fibrillation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      32
    term
    Steroid Withdrawal Syndrome
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      32
    term
    Retinal Artery Thrombosis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      32
    term
    Abdominal Pain
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      32
    term
    Diarrhoea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      32
    term
    Nausea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      32
    term
    Vomiting
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      32
    term
    Pyrexia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      32
    term
    Sudden Death
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      32
    term
    Cholelithiasis

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 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      8
      num At Risk
      32
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      32
    term
    Leukocytosis
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      8
      num At Risk
      32
    term
    Leukopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      32
    term
    Lymphopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      29
      num At Risk
      32
    term
    Neutropenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      11
      num At Risk
      32
    term
    Thrombocytopenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      32
    term
    Atrial Fibrillation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      32
    term
    Bradycardia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      32
    term
    Palpitations
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      32
    term
    Supraventricular Tachycardia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      32
    term
    Hearing Impaired
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      32
    term
    Tinnitus
Complete source fields
description
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Participants received daratumumab 2 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (cycles 3 to 6), Day 1 (cycle 7+) along with lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
    id
    EG000
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    2
    serious Num At Risk
    3
    title
    Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone
  2. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Participants administered with daratumumab 4 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
    id
    EG001
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    2
    serious Num At Risk
    3
    title
    Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone
  3. deaths Num Affected
    1
    deaths Num At Risk
    4
    description
    Participants received with daratumumab 8 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (cycles 3 to 6), Day 1 (cycle 7+) along with lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
    id
    EG002
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    3
    serious Num At Risk
    4
    title
    Phase 1: 8mg/kg Daratumumab + Lenalidomide and Dexamethasone
  4. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Participants administered with daratumumab 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
    id
    EG003
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    2
    serious Num At Risk
    3
    title
    Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
  5. deaths Num Affected
    1
    deaths Num At Risk
    32
    description
    Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
    id
    EG004
    other Num Affected
    31
    other Num At Risk
    32
    serious Num Affected
    22
    serious Num At Risk
    32
    title
    Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      8
      num At Risk
      32
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      32
    term
    Leukocytosis
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      8
      num At Risk
      32
    term
    Leukopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      32
    term
    Lymphopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      29
      num At Risk
      32
    term
    Neutropenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      11
      num At Risk
      32
    term
    Thrombocytopenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      32
    term
    Atrial Fibrillation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      32
    term
    Bradycardia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      32
    term
    Palpitations
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      32
    term
    Supraventricular Tachycardia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      32
    term
    Hearing Impaired
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      32
    term
    Tinnitus
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      32
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      32
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      32
    term
    Atrial Fibrillation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      32
    term
    Steroid Withdrawal Syndrome
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      32
    term
    Retinal Artery Thrombosis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      32
    term
    Abdominal Pain
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      32
    term
    Diarrhoea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      32
    term
    Nausea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      32
    term
    Vomiting
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      32
    term
    Pyrexia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      32
    term
    Sudden Death
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      32
    term
    Cholelithiasis
time Frame
Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice