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NCT04181827 · ADVERSE EVENTS

Adverse events

A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma · Source last updated 2026-08-31

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 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
Other-event reporting threshold
5%

All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A: Standard Therapy: PVd or DPd

Participants received either PVd or DPd as standard therapy. In pomalidomide, bortezomib and dexamethasone (PVd) treatment, participants received pomalidomide 4 milligrams (mg) orally (PO) on Days 1 to 14 in each treatment cycle; bortezomib 1.3 mg/meter square (m\^2) subcutaneous (SC) injection on Days 1, 4, 8 and 11 (Cycles 1 to 8) and on Days 1 and 8 (Cycle 9 onwards); and dexamethasone 20 mg (or 10 mg for participants aged greater than \[\>\] 75 years) PO on Days 1, 2, 4, 5, 8, 9, 11 and 12 (Cycles 1 to 8) and Days 1, 2, 8 and 9 (Cycle 9 onwards). Each treatment cycle of 21 days. In daratumumab, pomalidomide and dexamethasone (DPd) treatment, participants received daratumumab 1800 mg SC injection weekly on Days 1, 8, 15 and 22 (Cycle 1 and 2), every 2 weeks on Days 1 and 15 (Cycle 3 to 6) and every 4 weeks on Day 1 (Cycle 7 onwards); pomalidomide 4 mg PO on Days 1 to 21 (Cycle 1 onwards); dexamethasone 40 mg (or 20 mg for participants aged \>75 years) PO or intravenous(IV) weekly during Cycle 1-2 on Days 1, 8, 15, and 22 or split with 20 mg on Days 1, 2, 8, 9, 15, 16, 22, and 23. Each treatment cycle of 28 days. Participants continued to receive PVd or DPd until confirmed progressive disease (PD), death, intolerable toxicity, withdrawal of consent, or end of study, whichever occurred earlier.

98 / 208207 / 20883 / 211
Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel])

Participants received at least one cycle of bridging therapy, that is PVd: pomalidomide 4 mg PO on Days 1 to 14, bortezomib 1.3 mg/m\^2 SC injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg (or 10 mg for participants aged \>75 years) PO on Days 1, 2, 4, 5, 8, 9, 11, and 12; each treatment cycle of 21 days. DPd: daratumumab SC 1800 mg (co-formulated with rHuPH20) weekly on Days 1, 8, 15, and 22, pomalidomide 4 mg PO on Days 1 to 21, and dexamethasone PO or IV 40 mg (or 20 mg for participants aged \>75 years) weekly during Cycle 1-2 on Days 1, 8, 15, and 22 or split with 20 mg on Days 1, 2, 8, 9, 15, 16, 22, and 23. Each treatment cycle of 28 days. Additional cycles of bridging therapy was considered based on participant's clinical status and timing of availability of JNJ-68284528 (cilta-cel). Followed by bridging therapy, participants received conditioning regimen: cyclophosphamide 300 mg/m\^2 IV and fludarabine 30 mg/m\^2 IV daily, for 3 days on chimeric antigen receptor T cells (CAR-T) Day -5, -4, -3 (prior to JNJ-68284528 infusion), followed by JNJ-68284528 (cilta-cel) infusion 0.75\*10\^6 chimeric antigen receptor (CAR)-positive viable T cells per kilogram (kg) 5 to 7 days after the start of conditioning regimen.

98 / 208208 / 20850 / 208

Group identifiers: EG000: Arm A: Standard Therapy: PVd or DPd · EG001: Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel])

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
      208
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      208
    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
      0
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      208
    term
    Cytopenia
  3. 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
      6
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      208
    term
    Febrile Neutropenia
  4. 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
      208
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      208
    term
    Hyperviscosity Syndrome
  5. 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
      0
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      208
    term
    Immune Thrombocytopenia
  6. 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
      0
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      208
    term
    Lymphocytosis
  7. 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
      208
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      208
    term
    Neutropenia
  8. 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
      208
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      208
    term
    Pancytopenia
  9. 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
      0
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      208
    term
    Thrombocytopenia
  10. 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
      208
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      208
    term
    Acute Coronary Syndrome
  11. 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
      208
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      208
    term
    Acute Myocardial Infarction
  12. 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
      208
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      208
    term
    Angina Pectoris

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
      57
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      110
      num At Risk
      208
    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
      16
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      208
    term
    Leukopenia
  3. 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
      29
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      47
      num At Risk
      208
    term
    Lymphopenia
  4. 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
      178
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      187
      num At Risk
      208
    term
    Neutropenia
  5. 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
      67
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      113
      num At Risk
      208
    term
    Thrombocytopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      208
    term
    Cataract
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      208
    term
    Vision Blurred
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      208
    term
    Abdominal Pain
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      49
      num At Risk
      208
    term
    Constipation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      65
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      69
      num At Risk
      208
    term
    Diarrhoea
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      101
      num At Risk
      208
    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
      18
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      208
    term
    Vomiting
Complete source fields
description
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
event Groups
  1. deaths Num Affected
    83
    deaths Num At Risk
    211
    description
    Participants received either PVd or DPd as standard therapy. In pomalidomide, bortezomib and dexamethasone (PVd) treatment, participants received pomalidomide 4 milligrams (mg) orally (PO) on Days 1 to 14 in each treatment cycle; bortezomib 1.3 mg/meter square (m\^2) subcutaneous (SC) injection on Days 1, 4, 8 and 11 (Cycles 1 to 8) and on Days 1 and 8 (Cycle 9 onwards); and dexamethasone 20 mg (or 10 mg for participants aged greater than \[\>\] 75 years) PO on Days 1, 2, 4, 5, 8, 9, 11 and 12 (Cycles 1 to 8) and Days 1, 2, 8 and 9 (Cycle 9 onwards). Each treatment cycle of 21 days. In daratumumab, pomalidomide and dexamethasone (DPd) treatment, participants received daratumumab 1800 mg SC injection weekly on Days 1, 8, 15 and 22 (Cycle 1 and 2), every 2 weeks on Days 1 and 15 (Cycle 3 to 6) and every 4 weeks on Day 1 (Cycle 7 onwards); pomalidomide 4 mg PO on Days 1 to 21 (Cycle 1 onwards); dexamethasone 40 mg (or 20 mg for participants aged \>75 years) PO or intravenous(IV) weekly during Cycle 1-2 on Days 1, 8, 15, and 22 or split with 20 mg on Days 1, 2, 8, 9, 15, 16, 22, and 23. Each treatment cycle of 28 days. Participants continued to receive PVd or DPd until confirmed progressive disease (PD), death, intolerable toxicity, withdrawal of consent, or end of study, whichever occurred earlier.
    id
    EG000
    other Num Affected
    207
    other Num At Risk
    208
    serious Num Affected
    98
    serious Num At Risk
    208
    title
    Arm A: Standard Therapy: PVd or DPd
  2. deaths Num Affected
    50
    deaths Num At Risk
    208
    description
    Participants received at least one cycle of bridging therapy, that is PVd: pomalidomide 4 mg PO on Days 1 to 14, bortezomib 1.3 mg/m\^2 SC injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg (or 10 mg for participants aged \>75 years) PO on Days 1, 2, 4, 5, 8, 9, 11, and 12; each treatment cycle of 21 days. DPd: daratumumab SC 1800 mg (co-formulated with rHuPH20) weekly on Days 1, 8, 15, and 22, pomalidomide 4 mg PO on Days 1 to 21, and dexamethasone PO or IV 40 mg (or 20 mg for participants aged \>75 years) weekly during Cycle 1-2 on Days 1, 8, 15, and 22 or split with 20 mg on Days 1, 2, 8, 9, 15, 16, 22, and 23. Each treatment cycle of 28 days. Additional cycles of bridging therapy was considered based on participant's clinical status and timing of availability of JNJ-68284528 (cilta-cel). Followed by bridging therapy, participants received conditioning regimen: cyclophosphamide 300 mg/m\^2 IV and fludarabine 30 mg/m\^2 IV daily, for 3 days on chimeric antigen receptor T cells (CAR-T) Day -5, -4, -3 (prior to JNJ-68284528 infusion), followed by JNJ-68284528 (cilta-cel) infusion 0.75\*10\^6 chimeric antigen receptor (CAR)-positive viable T cells per kilogram (kg) 5 to 7 days after the start of conditioning regimen.
    id
    EG001
    other Num Affected
    208
    other Num At Risk
    208
    serious Num Affected
    98
    serious Num At Risk
    208
    title
    Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel])
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
      57
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      110
      num At Risk
      208
    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
      16
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      208
    term
    Leukopenia
  3. 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
      29
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      47
      num At Risk
      208
    term
    Lymphopenia
  4. 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
      178
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      187
      num At Risk
      208
    term
    Neutropenia
  5. 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
      67
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      113
      num At Risk
      208
    term
    Thrombocytopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      208
    term
    Cataract
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      208
    term
    Vision Blurred
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      208
    term
    Abdominal Pain
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      49
      num At Risk
      208
    term
    Constipation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      65
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      69
      num At Risk
      208
    term
    Diarrhoea
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      101
      num At Risk
      208
    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
      18
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      208
    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
      208
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      208
    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
      0
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      208
    term
    Cytopenia
  3. 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
      6
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      208
    term
    Febrile Neutropenia
  4. 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
      208
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      208
    term
    Hyperviscosity Syndrome
  5. 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
      0
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      208
    term
    Immune Thrombocytopenia
  6. 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
      0
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      208
    term
    Lymphocytosis
  7. 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
      208
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      208
    term
    Neutropenia
  8. 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
      208
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      208
    term
    Pancytopenia
  9. 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
      0
      num At Risk
      208
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      208
    term
    Thrombocytopenia
  10. 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
      208
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      208
    term
    Acute Coronary Syndrome
  11. 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
      208
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      208
    term
    Acute Myocardial Infarction
  12. 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
      208
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      208
    term
    Angina Pectoris
time Frame
All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months

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Preserved source evidence · Not medical advice