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NCT02253316 · ADVERSE EVENTS

Adverse events

Phase II Study of IRD (Ixazomib, Lenalidomide, Dexamethasone) Post Autologous Stem Cell Transplantation Followed by Maintenance Ixazomib or Lenalidomide for Multiple Myeloma · Source last updated 2025-11-10

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
-Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. -All-cause mortality time frame is from first dose of study treatment through 30 days after the completion of study treatment.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Consolidation: Ixazomib, Lenalidomide, & Dexamethasone

Consolidation therapy will begin between Day 80 and Day 120 following ASCT and will consist of four 28-day cycles of IRD (ixazomib, lenalidomide, \& dexamethasone). Barring dose modifications for toxicity, 4 mg of ixazomib and 40 mg of dexamethasone will be administered on Days 1, 8, and 15, and 15 mg of lenalidomide will be administered on daily on Days 1-21.

44 / 236236 / 2361 / 236
Maintenance Arm 1: Ixazomib

Ixazomib will be administered on Days 1, 8, and 15 of a 28-day cycle at a starting dose of 4 mg until patient progresses or experiences an unacceptable toxicity.

24 / 9999 / 990 / 99
Maintenance Arm 2: Lenalidomide

Lenalidomide will be administered daily continuously for a 28-day cycle at a starting dose of 10 mg. If lenalidomide is tolerated well (i.e. no dose modification required) during the first three cycles, lenalidomide dose will be increased to 15 mg daily and will continue until patient progresses or experiences an unacceptable toxicity.

48 / 116116 / 1161 / 116

Group identifiers: EG000: Consolidation: Ixazomib, Lenalidomide, & Dexamethasone · EG001: Maintenance Arm 1: Ixazomib · EG002: Maintenance Arm 2: Lenalidomide

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
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      116
    term
    Acute coronary syndrome
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      116
    term
    Cardiac arrest
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      116
    term
    Coronary artery calcification
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      116
    term
    Coronary artery occlusion
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      116
    term
    Myocardial infarction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      116
    term
    Pericardial effusion
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      116
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      116
    term
    Diarrhea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      116
    term
    Gastric ulcer
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      116
    term
    Gastritis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      116
    term
    Ileus
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      116
    term
    Lower gastrointestinal hemorrhage

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
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      120
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      60
      num At Risk
      116
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      116
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      116
    term
    Hemolysis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      116
    term
    Leukocytosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      116
    term
    Thrombotic thrombocytopenic purpura
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      116
    term
    Arrhythmia NOS
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      116
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      116
    term
    Atrial flutter
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      116
    term
    Chest pain - cardiac
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      116
    term
    Heart murmur
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      116
    term
    Palpitations
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      116
    term
    Sinus bradycardia
Complete source fields
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    236
    description
    Consolidation therapy will begin between Day 80 and Day 120 following ASCT and will consist of four 28-day cycles of IRD (ixazomib, lenalidomide, \& dexamethasone). Barring dose modifications for toxicity, 4 mg of ixazomib and 40 mg of dexamethasone will be administered on Days 1, 8, and 15, and 15 mg of lenalidomide will be administered on daily on Days 1-21.
    id
    EG000
    other Num Affected
    236
    other Num At Risk
    236
    serious Num Affected
    44
    serious Num At Risk
    236
    title
    Consolidation: Ixazomib, Lenalidomide, & Dexamethasone
  2. deaths Num Affected
    0
    deaths Num At Risk
    99
    description
    Ixazomib will be administered on Days 1, 8, and 15 of a 28-day cycle at a starting dose of 4 mg until patient progresses or experiences an unacceptable toxicity.
    id
    EG001
    other Num Affected
    99
    other Num At Risk
    99
    serious Num Affected
    24
    serious Num At Risk
    99
    title
    Maintenance Arm 1: Ixazomib
  3. deaths Num Affected
    1
    deaths Num At Risk
    116
    description
    Lenalidomide will be administered daily continuously for a 28-day cycle at a starting dose of 10 mg. If lenalidomide is tolerated well (i.e. no dose modification required) during the first three cycles, lenalidomide dose will be increased to 15 mg daily and will continue until patient progresses or experiences an unacceptable toxicity.
    id
    EG002
    other Num Affected
    116
    other Num At Risk
    116
    serious Num Affected
    48
    serious Num At Risk
    116
    title
    Maintenance Arm 2: Lenalidomide
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      120
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      60
      num At Risk
      116
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      116
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      116
    term
    Hemolysis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      116
    term
    Leukocytosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      116
    term
    Thrombotic thrombocytopenic purpura
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      116
    term
    Arrhythmia NOS
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      116
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      116
    term
    Atrial flutter
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      116
    term
    Chest pain - cardiac
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      116
    term
    Heart murmur
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      116
    term
    Palpitations
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      116
    term
    Sinus bradycardia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      116
    term
    Acute coronary syndrome
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      116
    term
    Cardiac arrest
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      116
    term
    Coronary artery calcification
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      116
    term
    Coronary artery occlusion
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      116
    term
    Myocardial infarction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      116
    term
    Pericardial effusion
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      116
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      116
    term
    Diarrhea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      116
    term
    Gastric ulcer
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      116
    term
    Gastritis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      116
    term
    Ileus
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      116
    term
    Lower gastrointestinal hemorrhage
time Frame
-Adverse events were collected from first dose of study treatment through 30 days after the completion of study treatment. -All-cause mortality time frame is from first dose of study treatment through 30 days after the completion of study treatment.

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Preserved source evidence · Not medical advice