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NCT02005471 · ADVERSE EVENTS

Adverse events

A Study to Evaluate the Benefit of Venetoclax Plus Rituximab Compared With Bendamustine Plus Rituximab in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) · Source last updated 2023-10-17

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 signing of informed consent form up to approximately 8 years 5 months
Other-event reporting threshold
5%

SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Bendamustine + Rituximab Main Study

Participants received bendamustine at a dose of 70 mg/m\^2 via IV infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.

84 / 188177 / 18884 / 188
Venetoclax + Rituximab Main Study

Participants were initially placed on a venetoclax ramp-up period of 5 weeks, and received an initial dose of 20 mg via tablet orally QD for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg via tablet orally QD. Participants continued receiving venetoclax at a dose of 400 mg via tablet orally QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.

101 / 194190 / 19460 / 194
Bendamustine + Rituximab Crossover Substudy

Participants who entered the crossover substudy had a 5-week venetoclax dose ramp-up period to reach the target dose of 400 mg QD. Following the venetoclax ramp-up period, participants received 6 cycles of rituximab, 375 mg/m\^2, as IV infusion on the Day 1 of each 28-day cycle. Participants who did not progress following the completion of the 6 cycles continued to receive venetoclax monotherapy until disease progression or for a maximum of 2 years from Cycle 1 crossover Day 1 of the substudy.

5 / 95 / 91 / 9
Venetoclax + Rituximab Re-Treatment Substudy

Participants who entered the re-treatment substudy had a 5-week venetoclax dose ramp-up period to reach the target dose of 400 mg QD. Following the venetoclax ramp-up period, participants received 6 cycles of rituximab consisting of a single infusion on the first day of each 28-day cycle. Participants who did not progress following the completion of the 6 cycles continued to receive venetoclax monotherapy until disease progression or for a maximum of 2 year from Cycle 1 re-treatment Day 1 of the substudy.

13 / 259 / 258 / 25

Group identifiers: EG000: Bendamustine + Rituximab Main Study · EG001: Venetoclax + Rituximab Main Study · EG002: Bendamustine + Rituximab Crossover Substudy · EG003: Venetoclax + Rituximab Re-Treatment Substudy

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 v25.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      188
      num Events
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      194
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      188
      num Events
      4
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      194
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Autoimmune haemolytic anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      188
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      194
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Disseminated intravascular coagulation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      188
      num Events
      16
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      194
      num Events
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      188
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      194
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Leukocytosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      188
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      194
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      188
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      194
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Pancytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      188
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      194
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Thrombocytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      188
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      194
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Acute myocardial infarction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      188
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      194
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Angina pectoris
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      188
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      194
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Atrial fibrillation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      188
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      194
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Cardiac failure

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 v25.0
    stats
    1. group Id
      EG000
      num Affected
      40
      num At Risk
      188
      num Events
      68
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      194
      num Events
      48
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      84
      num At Risk
      188
      num Events
      182
    2. group Id
      EG001
      num Affected
      120
      num At Risk
      194
      num Events
      290
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      9
      num Events
      5
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      25
      num Events
      13
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      188
      num Events
      57
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      194
      num Events
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      188
      num Events
      7
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      194
      num Events
      14
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      188
      num Events
      47
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      194
      num Events
      31
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      188
      num Events
      43
    2. group Id
      EG001
      num Affected
      78
      num At Risk
      194
      num Events
      120
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      25
      num Events
      4
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      64
      num At Risk
      188
      num Events
      82
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      194
      num Events
      58
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      188
      num Events
      29
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      194
      num Events
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Vomiting
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      188
      num Events
      14
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      194
      num Events
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Bronchitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      188
      num Events
      5
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      194
      num Events
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Conjunctivitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      188
      num Events
      4
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      194
      num Events
      15
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Lower respiratory tract infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      188
      num Events
      15
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      194
      num Events
      29
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Nasopharyngitis
Complete source fields
description
SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
event Groups
  1. deaths Num Affected
    84
    deaths Num At Risk
    188
    description
    Participants received bendamustine at a dose of 70 mg/m\^2 via IV infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
    id
    EG000
    other Num Affected
    177
    other Num At Risk
    188
    serious Num Affected
    84
    serious Num At Risk
    188
    title
    Bendamustine + Rituximab Main Study
  2. deaths Num Affected
    60
    deaths Num At Risk
    194
    description
    Participants were initially placed on a venetoclax ramp-up period of 5 weeks, and received an initial dose of 20 mg via tablet orally QD for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg via tablet orally QD. Participants continued receiving venetoclax at a dose of 400 mg via tablet orally QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
    id
    EG001
    other Num Affected
    190
    other Num At Risk
    194
    serious Num Affected
    101
    serious Num At Risk
    194
    title
    Venetoclax + Rituximab Main Study
  3. deaths Num Affected
    1
    deaths Num At Risk
    9
    description
    Participants who entered the crossover substudy had a 5-week venetoclax dose ramp-up period to reach the target dose of 400 mg QD. Following the venetoclax ramp-up period, participants received 6 cycles of rituximab, 375 mg/m\^2, as IV infusion on the Day 1 of each 28-day cycle. Participants who did not progress following the completion of the 6 cycles continued to receive venetoclax monotherapy until disease progression or for a maximum of 2 years from Cycle 1 crossover Day 1 of the substudy.
    id
    EG002
    other Num Affected
    5
    other Num At Risk
    9
    serious Num Affected
    5
    serious Num At Risk
    9
    title
    Bendamustine + Rituximab Crossover Substudy
  4. deaths Num Affected
    8
    deaths Num At Risk
    25
    description
    Participants who entered the re-treatment substudy had a 5-week venetoclax dose ramp-up period to reach the target dose of 400 mg QD. Following the venetoclax ramp-up period, participants received 6 cycles of rituximab consisting of a single infusion on the first day of each 28-day cycle. Participants who did not progress following the completion of the 6 cycles continued to receive venetoclax monotherapy until disease progression or for a maximum of 2 year from Cycle 1 re-treatment Day 1 of the substudy.
    id
    EG003
    other Num Affected
    9
    other Num At Risk
    25
    serious Num Affected
    13
    serious Num At Risk
    25
    title
    Venetoclax + Rituximab Re-Treatment Substudy
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      40
      num At Risk
      188
      num Events
      68
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      194
      num Events
      48
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      84
      num At Risk
      188
      num Events
      182
    2. group Id
      EG001
      num Affected
      120
      num At Risk
      194
      num Events
      290
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      9
      num Events
      5
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      25
      num Events
      13
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      188
      num Events
      57
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      194
      num Events
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      188
      num Events
      7
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      194
      num Events
      14
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      188
      num Events
      47
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      194
      num Events
      31
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      188
      num Events
      43
    2. group Id
      EG001
      num Affected
      78
      num At Risk
      194
      num Events
      120
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      25
      num Events
      4
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      64
      num At Risk
      188
      num Events
      82
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      194
      num Events
      58
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      188
      num Events
      29
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      194
      num Events
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Vomiting
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      188
      num Events
      14
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      194
      num Events
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Bronchitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      188
      num Events
      5
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      194
      num Events
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Conjunctivitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      188
      num Events
      4
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      194
      num Events
      15
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Lower respiratory tract infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      188
      num Events
      15
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      194
      num Events
      29
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Nasopharyngitis
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      188
      num Events
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      194
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      188
      num Events
      4
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      194
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Autoimmune haemolytic anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      188
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      194
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Disseminated intravascular coagulation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      188
      num Events
      16
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      194
      num Events
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      188
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      194
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Leukocytosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      188
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      194
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      188
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      194
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Pancytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      188
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      194
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Thrombocytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      188
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      194
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Acute myocardial infarction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      188
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      194
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Angina pectoris
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      188
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      194
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Atrial fibrillation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      188
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      194
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Cardiac failure
time Frame
From signing of informed consent form up to approximately 8 years 5 months

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Preserved source evidence · Not medical advice