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NCT01946477 · ADVERSE EVENTS

Adverse events

Pomalidomide in Combination With Low-dose Dexamethasone or Pomalidomide in Combination With Low-dose Dexamethasone and Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma Following Lenalidomide-based Therapy in the First or Second Line Setting · Source last updated 2026-06-15

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
Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort A

(Pomalidomide + low dose Dexamethasone) in participants with 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old).

30 / 5656 / 5631 / 56
Cohort B

(Pomalidomide + Daratumumab + low dose Dexamethasone) in participants with 1 or 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old). DARA was administered intravenously (IV) at a starting dose of 16 mg/kg.

69 / 112112 / 11251 / 112
Cohort C

(Pomalidomide + Daratumumab + low dose Dexamethasone) in Japanese participants with 1 or 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old). DARA was administered intravenously (IV) at a starting dose of 16 mg/kg.

11 / 1818 / 188 / 18

Group identifiers: EG000: Cohort A · EG001: Cohort B · EG002: Cohort C

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
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      56
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      112
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      56
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      112
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    term
    Atypical haemolytic uraemic syndrome
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      56
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      112
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      112
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      56
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      112
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    term
    Pancytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      112
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      112
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    term
    Acute myocardial infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      56
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      112
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      112
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    term
    Atrial flutter
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      56
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      112
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    term
    Cardiac arrest
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      112
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
    term
    Cardiac failure chronic
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      56
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      112
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    term
    Cardiac failure congestive

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
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      56
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      112
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      18
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      112
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      112
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      18
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      112
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      18
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      56
    2. group Id
      EG001
      num Affected
      75
      num At Risk
      112
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      18
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      56
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      112
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      18
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      56
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      112
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      112
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
    term
    Cardiac failure chronic
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      56
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      112
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    term
    Tachycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      112
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
    term
    Adrenal insufficiency
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      56
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      112
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
    term
    Cushingoid
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      56
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      112
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      18
    term
    Cataract
Complete source fields
event Groups
  1. deaths Num Affected
    31
    deaths Num At Risk
    56
    description
    (Pomalidomide + low dose Dexamethasone) in participants with 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old).
    id
    EG000
    other Num Affected
    56
    other Num At Risk
    56
    serious Num Affected
    30
    serious Num At Risk
    56
    title
    Cohort A
  2. deaths Num Affected
    51
    deaths Num At Risk
    112
    description
    (Pomalidomide + Daratumumab + low dose Dexamethasone) in participants with 1 or 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old). DARA was administered intravenously (IV) at a starting dose of 16 mg/kg.
    id
    EG001
    other Num Affected
    112
    other Num At Risk
    112
    serious Num Affected
    69
    serious Num At Risk
    112
    title
    Cohort B
  3. deaths Num Affected
    8
    deaths Num At Risk
    18
    description
    (Pomalidomide + Daratumumab + low dose Dexamethasone) in Japanese participants with 1 or 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old). DARA was administered intravenously (IV) at a starting dose of 16 mg/kg.
    id
    EG002
    other Num Affected
    18
    other Num At Risk
    18
    serious Num Affected
    11
    serious Num At Risk
    18
    title
    Cohort C
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      56
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      112
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      18
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      112
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      112
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      18
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      112
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      18
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      56
    2. group Id
      EG001
      num Affected
      75
      num At Risk
      112
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      18
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      56
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      112
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      18
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      56
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      112
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      112
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
    term
    Cardiac failure chronic
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      56
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      112
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    term
    Tachycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      112
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
    term
    Adrenal insufficiency
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      56
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      112
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
    term
    Cushingoid
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      56
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      112
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      18
    term
    Cataract
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      56
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      112
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      56
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      112
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    term
    Atypical haemolytic uraemic syndrome
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      56
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      112
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      112
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      56
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      112
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    term
    Pancytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      112
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      112
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    term
    Acute myocardial infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      56
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      112
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      112
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    term
    Atrial flutter
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      56
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      112
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    term
    Cardiac arrest
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      112
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
    term
    Cardiac failure chronic
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      56
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      112
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    term
    Cardiac failure congestive
time Frame
Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 130 months). SAEs and Other AEs were assessed from first dose through 30 days following last dose of study treatment (up to approximately 120 months).

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