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NCT02165397 · ADVERSE EVENTS

Adverse events

Ibrutinib With Rituximab in Adults With Waldenström's Macroglobulinemia · Source last updated 2021-03-03

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
From first dose of study drug up to 30 days after the last dose of study drug. Median duration of treatment was 47.7 months for the Ibr+R arm, 15.5 months for the Pbo+R arm, and 40.7 months for the Open-Label Ibr arm.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Ibrutinib + Rituximab

Ibrutinib: 420 mg (3 capsules) orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment. Rituximab: 375 mg/m\^2 IV per package insert weekly for four consecutive weeks (Day 1 of Weeks 1-4), followed by a second four-weekly rituximab course after a three-month interval (Weeks 17-20) for a total of 8 infusions of rituximab.

40 / 7575 / 759 / 75
Placebo + Rituximab

Placebo: 3 capsules of placebo orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment. Rituximab: 375 mg/m\^2 IV per package insert weekly for four consecutive weeks (Day 1 of Weeks 1-4), followed by a second four-weekly rituximab course after a three-month interval (Weeks 17-20) for a total of 8 infusions of rituximab.

25 / 7575 / 7510 / 75
Open-Label Substudy: Ibrutinib

Ibrutinib: 420 mg (3 capsules) orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment.

16 / 3130 / 318 / 31

Group identifiers: EG000: Ibrutinib + Rituximab · EG001: Placebo + Rituximab · EG002: Open-Label Substudy: Ibrutinib

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 22.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      75
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      75
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      31
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      75
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
    term
    Immune thrombocytopenic purpura
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      75
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      75
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      31
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      75
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      31
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      75
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
    term
    Angina pectoris
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      75
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
    term
    Angina unstable
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      75
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
    term
    Atrial fibrillation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      75
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
    term
    Cardiac failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      75
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
    term
    Cardiac tamponade
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      75
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
    term
    Coronary artery disease

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 22.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      75
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      31
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      75
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      31
    term
    Increased tendency to bruise
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      75
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      31
    term
    Lymphadenopathy
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      75
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      31
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      75
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      31
    term
    Spontaneous haematoma
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      75
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      31
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      75
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      75
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      31
    term
    Palpitations
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      75
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      31
    term
    Tinnitus
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      75
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      31
    term
    Cataract
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      75
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      31
    term
    Diplopia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      75
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      31
    term
    Dry eye
Complete source fields
event Groups
  1. deaths Num Affected
    9
    deaths Num At Risk
    75
    description
    Ibrutinib: 420 mg (3 capsules) orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment. Rituximab: 375 mg/m\^2 IV per package insert weekly for four consecutive weeks (Day 1 of Weeks 1-4), followed by a second four-weekly rituximab course after a three-month interval (Weeks 17-20) for a total of 8 infusions of rituximab.
    id
    EG000
    other Num Affected
    75
    other Num At Risk
    75
    serious Num Affected
    40
    serious Num At Risk
    75
    title
    Ibrutinib + Rituximab
  2. deaths Num Affected
    10
    deaths Num At Risk
    75
    description
    Placebo: 3 capsules of placebo orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment. Rituximab: 375 mg/m\^2 IV per package insert weekly for four consecutive weeks (Day 1 of Weeks 1-4), followed by a second four-weekly rituximab course after a three-month interval (Weeks 17-20) for a total of 8 infusions of rituximab.
    id
    EG001
    other Num Affected
    75
    other Num At Risk
    75
    serious Num Affected
    25
    serious Num At Risk
    75
    title
    Placebo + Rituximab
  3. deaths Num Affected
    8
    deaths Num At Risk
    31
    description
    Ibrutinib: 420 mg (3 capsules) orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment.
    id
    EG002
    other Num Affected
    30
    other Num At Risk
    31
    serious Num Affected
    16
    serious Num At Risk
    31
    title
    Open-Label Substudy: Ibrutinib
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      75
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      31
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      75
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      31
    term
    Increased tendency to bruise
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      75
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      31
    term
    Lymphadenopathy
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      75
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      31
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      75
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      31
    term
    Spontaneous haematoma
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      75
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      31
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      75
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      75
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      31
    term
    Palpitations
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      75
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      31
    term
    Tinnitus
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      75
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      31
    term
    Cataract
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      75
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      31
    term
    Diplopia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      75
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      31
    term
    Dry eye
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      75
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      75
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      31
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      75
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
    term
    Immune thrombocytopenic purpura
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      75
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      75
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      31
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      75
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      31
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      75
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
    term
    Angina pectoris
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      75
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
    term
    Angina unstable
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      75
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
    term
    Atrial fibrillation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      75
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
    term
    Cardiac failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      75
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
    term
    Cardiac tamponade
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      75
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
    term
    Coronary artery disease
time Frame
From first dose of study drug up to 30 days after the last dose of study drug. Median duration of treatment was 47.7 months for the Ibr+R arm, 15.5 months for the Pbo+R arm, and 40.7 months for the Open-Label Ibr arm.

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Preserved source evidence · Not medical advice