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NCT02970318 · ADVERSE EVENTS

Adverse events

A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL · Source last updated 2026-07-24

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 adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.
Other-event reporting threshold
0%

Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A- Acala. 100 mg BID

Arm A- Acalabrutinib 100 mg BID

70 / 154149 / 15441 / 155
Arm B: Investigator Choice (IR or BR)-Main Study Period

IR or BR data not presented separately similar to combined treatment arms approved for D8223C00009

86 / 153145 / 15333 / 155
Arm B Cross Over

Arm B Investigator Choice Crossed Over to Acalabrutinib

31 / 8073 / 8020 / 80

Group identifiers: EG000: Arm A- Acala. 100 mg BID · EG001: Arm B: Investigator Choice (IR or BR)-Main Study Period · EG002: Arm B Cross Over

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      154
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
      num Events
      0
    term
    Gastric ulcer
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      154
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
      num Events
      0
    term
    Gastrointestinal haemorrhage
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      154
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
      num Events
      0
    term
    Immune thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      154
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      153
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
      num Events
      0
    term
    Incarcerated umbilical hernia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      154
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      153
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
      num Events
      0
    term
    Intestinal haemorrhage
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      154
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
      num Events
      0
    term
    Oesophagitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      154
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
      num Events
      0
    term
    Pancreatitis acute
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      154
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      153
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
      num Events
      0
    term
    Chest pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      154
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
      num Events
      0
    term
    Chills
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      154
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
      num Events
      0
    term
    Condition aggravated
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      154
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
      num Events
      0
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      154
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      153
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
      num Events
      0
    term
    General physical health deterioration

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 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      154
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      153
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
      num Events
      0
    term
    Hyperleukocytosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      154
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
      num Events
      0
    term
    Gastric mucosa erythema
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      154
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      153
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
      num Events
      0
    term
    Gastric polyps
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      154
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      153
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
      num Events
      0
    term
    Gastric ulcer perforation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      154
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
      num Events
      0
    term
    Gastritis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      154
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
      num Events
      0
    term
    Gastrointestinal angiectasia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      154
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
      num Events
      0
    term
    Gastrointestinal disorder
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      154
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
      num Events
      0
    term
    Gastrointestinal inflammation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      154
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
      num Events
      0
    term
    Gastrointestinal toxicity
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      154
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
      num Events
      0
    term
    Immune thrombocytopenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      154
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      153
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
      num Events
      0
    term
    Gastrointestinal tract mucosal pigmentation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      154
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
      num Events
      0
    term
    Gastrooesophageal reflux disease
Complete source fields
description
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.
event Groups
  1. deaths Num Affected
    41
    deaths Num At Risk
    155
    description
    Arm A- Acalabrutinib 100 mg BID
    id
    EG000
    other Num Affected
    149
    other Num At Risk
    154
    serious Num Affected
    70
    serious Num At Risk
    154
    title
    Arm A- Acala. 100 mg BID
  2. deaths Num Affected
    33
    deaths Num At Risk
    155
    description
    IR or BR data not presented separately similar to combined treatment arms approved for D8223C00009
    id
    EG001
    other Num Affected
    145
    other Num At Risk
    153
    serious Num Affected
    86
    serious Num At Risk
    153
    title
    Arm B: Investigator Choice (IR or BR)-Main Study Period
  3. deaths Num Affected
    20
    deaths Num At Risk
    80
    description
    Arm B Investigator Choice Crossed Over to Acalabrutinib
    id
    EG002
    other Num Affected
    73
    other Num At Risk
    80
    serious Num Affected
    31
    serious Num At Risk
    80
    title
    Arm B Cross Over
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      154
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      153
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
      num Events
      0
    term
    Hyperleukocytosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      154
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
      num Events
      0
    term
    Gastric mucosa erythema
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      154
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      153
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
      num Events
      0
    term
    Gastric polyps
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      154
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      153
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
      num Events
      0
    term
    Gastric ulcer perforation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      154
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
      num Events
      0
    term
    Gastritis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      154
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
      num Events
      0
    term
    Gastrointestinal angiectasia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      154
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
      num Events
      0
    term
    Gastrointestinal disorder
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      154
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
      num Events
      0
    term
    Gastrointestinal inflammation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      154
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
      num Events
      0
    term
    Gastrointestinal toxicity
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      154
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
      num Events
      0
    term
    Immune thrombocytopenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      154
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      153
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
      num Events
      0
    term
    Gastrointestinal tract mucosal pigmentation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      154
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
      num Events
      0
    term
    Gastrooesophageal reflux disease
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      154
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
      num Events
      0
    term
    Gastric ulcer
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      154
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
      num Events
      0
    term
    Gastrointestinal haemorrhage
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      154
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
      num Events
      0
    term
    Immune thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      154
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      153
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
      num Events
      0
    term
    Incarcerated umbilical hernia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      154
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      153
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
      num Events
      0
    term
    Intestinal haemorrhage
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      154
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
      num Events
      0
    term
    Oesophagitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      154
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
      num Events
      0
    term
    Pancreatitis acute
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      154
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      153
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
      num Events
      0
    term
    Chest pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      154
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
      num Events
      0
    term
    Chills
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      154
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
      num Events
      0
    term
    Condition aggravated
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      154
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
      num Events
      0
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      154
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      153
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
      num Events
      0
    term
    General physical health deterioration
time Frame
All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.

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Preserved source evidence · Not medical advice