Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02242942 · ADVERSE EVENTS

Adverse events

Comparison of the Treatments of Obinutuzumab + Venetoclax Versus Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia · Source last updated 2025-11-06

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
All AEs from first dose until 28 days after the last dose up to 1 year. Grade 3-4 AEs: for 6 months after last dose (up to 1.5 years). Major infections (Grade 3-4): for 2 years after the last dose (up to 3 years) irrespective of causality unless disease progressed and participant received leukemic treatment. Before disease progression, SAEs were reported during follow-up (up to 3.75 years). After disease progression, only related SAEs and second primary malignancies were reported.
Other-event reporting threshold
5%

All-cause mortality was based on the ITT population defined as all randomized participants. Reporting of serious and non-serious adverse events was based on the safety population defined as all participants who received at least one dose of any study medication (i.e., obinutuzumab, venetoclax, or chlorambucil).

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Obinutuzumab + Chlorambucil

Participants will receive obinutuzumab for 6 cycles and chlorambucil for 12 cycles. Cycles will comprise 28 days.

90 / 214205 / 21417 / 216
Obinutuzumab + Venetoclax

Participants will receive obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles will comprise 28 days.

104 / 212193 / 21220 / 216
Safety Run-in Obinutuzumab + Venetoclax

Subjects received obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles comprised of 28 days.

10 / 1312 / 132 / 13

Group identifiers: EG000: Obinutuzumab + Chlorambucil · EG001: Obinutuzumab + Venetoclax · EG002: Safety Run-in Obinutuzumab + Venetoclax

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, version 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      214
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      212
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA, version 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      214
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      212
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Autoimmune haemolytic anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA, version 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      214
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      212
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Coombs negative haemolytic anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA, version 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      214
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      212
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Disseminated intravascular coagulation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA, version 21.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      214
      num Events
      10
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      212
      num Events
      12
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      13
      num Events
      3
    term
    Febrile neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA, version 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      214
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      212
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Immune thrombocytopenic purpura
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA, version 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      214
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      212
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Neutropenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA, version 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      214
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      212
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Pancytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA, version 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      214
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      212
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Splenic infarction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA, version 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      214
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      212
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Splenomegaly
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA, version 21.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      214
      num Events
      5
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      212
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Thrombocytopenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA, version 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      214
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      212
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Acute myocardial infarction

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, version 21.0
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      214
      num Events
      55
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      212
      num Events
      53
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      13
      num Events
      2
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA, version 21.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      214
      num Events
      19
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      212
      num Events
      23
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA, version 21.0
    stats
    1. group Id
      EG000
      num Affected
      122
      num At Risk
      214
      num Events
      294
    2. group Id
      EG001
      num Affected
      121
      num At Risk
      212
      num Events
      370
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      13
      num Events
      12
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA, version 21.0
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      214
      num Events
      76
    2. group Id
      EG001
      num Affected
      49
      num At Risk
      212
      num Events
      86
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      13
      num Events
      5
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA, version 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      214
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      212
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Coronary artery disease
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA, version 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      214
      num Events
      1
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      212
      num Events
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA, version 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      214
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      212
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Ventricular extrasystoles
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA, version 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      214
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      212
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Excessive cerumen production
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA, version 21.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      214
      num Events
      11
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      212
      num Events
      15
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      13
      num Events
      2
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA, version 21.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      214
      num Events
      4
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      212
      num Events
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Abdominal pain upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA, version 21.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      214
      num Events
      23
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      212
      num Events
      32
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      13
      num Events
      6
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA, version 21.0
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      214
      num Events
      42
    2. group Id
      EG001
      num Affected
      59
      num At Risk
      212
      num Events
      99
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      13
      num Events
      8
    term
    Diarrhoea
Complete source fields
description
All-cause mortality was based on the ITT population defined as all randomized participants. Reporting of serious and non-serious adverse events was based on the safety population defined as all participants who received at least one dose of any study medication (i.e., obinutuzumab, venetoclax, or chlorambucil).
event Groups
  1. deaths Num Affected
    17
    deaths Num At Risk
    216
    description
    Participants will receive obinutuzumab for 6 cycles and chlorambucil for 12 cycles. Cycles will comprise 28 days.
    id
    EG000
    other Num Affected
    205
    other Num At Risk
    214
    serious Num Affected
    90
    serious Num At Risk
    214
    title
    Obinutuzumab + Chlorambucil
  2. deaths Num Affected
    20
    deaths Num At Risk
    216
    description
    Participants will receive obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles will comprise 28 days.
    id
    EG001
    other Num Affected
    193
    other Num At Risk
    212
    serious Num Affected
    104
    serious Num At Risk
    212
    title
    Obinutuzumab + Venetoclax
  3. deaths Num Affected
    2
    deaths Num At Risk
    13
    description
    Subjects received obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles comprised of 28 days.
    id
    EG002
    other Num Affected
    12
    other Num At Risk
    13
    serious Num Affected
    10
    serious Num At Risk
    13
    title
    Safety Run-in Obinutuzumab + Venetoclax
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA, version 21.0
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      214
      num Events
      55
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      212
      num Events
      53
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      13
      num Events
      2
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA, version 21.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      214
      num Events
      19
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      212
      num Events
      23
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA, version 21.0
    stats
    1. group Id
      EG000
      num Affected
      122
      num At Risk
      214
      num Events
      294
    2. group Id
      EG001
      num Affected
      121
      num At Risk
      212
      num Events
      370
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      13
      num Events
      12
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA, version 21.0
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      214
      num Events
      76
    2. group Id
      EG001
      num Affected
      49
      num At Risk
      212
      num Events
      86
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      13
      num Events
      5
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA, version 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      214
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      212
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Coronary artery disease
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA, version 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      214
      num Events
      1
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      212
      num Events
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA, version 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      214
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      212
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Ventricular extrasystoles
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA, version 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      214
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      212
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Excessive cerumen production
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA, version 21.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      214
      num Events
      11
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      212
      num Events
      15
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      13
      num Events
      2
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA, version 21.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      214
      num Events
      4
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      212
      num Events
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Abdominal pain upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA, version 21.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      214
      num Events
      23
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      212
      num Events
      32
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      13
      num Events
      6
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA, version 21.0
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      214
      num Events
      42
    2. group Id
      EG001
      num Affected
      59
      num At Risk
      212
      num Events
      99
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      13
      num Events
      8
    term
    Diarrhoea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA, version 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      214
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      212
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA, version 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      214
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      212
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Autoimmune haemolytic anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA, version 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      214
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      212
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Coombs negative haemolytic anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA, version 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      214
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      212
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Disseminated intravascular coagulation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA, version 21.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      214
      num Events
      10
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      212
      num Events
      12
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      13
      num Events
      3
    term
    Febrile neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA, version 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      214
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      212
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Immune thrombocytopenic purpura
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA, version 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      214
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      212
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Neutropenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA, version 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      214
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      212
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Pancytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA, version 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      214
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      212
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Splenic infarction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA, version 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      214
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      212
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Splenomegaly
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA, version 21.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      214
      num Events
      5
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      212
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Thrombocytopenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA, version 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      214
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      212
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Acute myocardial infarction
time Frame
All AEs from first dose until 28 days after the last dose up to 1 year. Grade 3-4 AEs: for 6 months after last dose (up to 1.5 years). Major infections (Grade 3-4): for 2 years after the last dose (up to 3 years) irrespective of causality unless disease progressed and participant received leukemic treatment. Before disease progression, SAEs were reported during follow-up (up to 3.75 years). After disease progression, only related SAEs and second primary malignancies were reported.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice