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NCT02989857 · ADVERSE EVENTS

Adverse events

Study of AG-120 in Previously Treated Advanced Cholangiocarcinoma With IDH1 Mutations (ClarIDHy) · Source last updated 2024-08-20

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

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

Collection time frame
From first dose of study drug up to 28 days after last dose for each intervention (Up to approximately 4 years)
Other-event reporting threshold
5%

All-Cause Mortality was assessed as per ITT population. Adverse Events: Safety Analysis Set included all participants who received at least one dose of study treatment.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
AG-120

Participants received AG-120 500 mg, tablet, orally, once daily (QD) in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up, or the sponsor ended the study for up to approximately 45 months.

43 / 123118 / 12399 / 126
Placebo

Participants received AG-120 matched placebo, orally, QD in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up or the sponsor ended the study for up to approximately 7 months. Participants who experienced disease progression and received placebo were allowed to cross over and receive AG-120.

14 / 5956 / 5914 / 61
After Cross Over to AG-120

Participants who experienced disease progression and received placebo were allowed to cross over to receive AG-120 500 mg, tablet, orally, QD in each 28-day treatment cycle for up to approximately 32 months.

12 / 4336 / 4334 / 43

Group identifiers: EG000: AG-120 · EG001: Placebo · EG002: After Cross Over to AG-120

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 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      123
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      43
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      123
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      43
    term
    Tachyarrhythmia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      123
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      43
    term
    Vertigo
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      123
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      43
    term
    Abdominal distension
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      123
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      43
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      123
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      43
    term
    Abdominal pain lower
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      123
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      43
    term
    Ascites
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      123
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      43
    term
    Dysphagia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      123
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      43
    term
    Gastrointestinal haemorrhage
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      123
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      43
    term
    Intestinal obstruction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      123
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      43
    term
    Intestinal pseudo-obstruction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      123
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      43
    term
    Large intestinal obstruction

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      52
      num At Risk
      123
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      43
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      123
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      43
    term
    Diarrhoea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      123
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      43
    term
    Fatigue
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      123
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      43
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      123
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      43
    term
    Cough
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      123
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      43
    term
    Decreased appetite
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      123
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      43
    term
    Ascites
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      123
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      43
    term
    Vomiting
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      123
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      43
    term
    Anaemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      123
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      43
    term
    Oedema peripheral
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      123
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      43
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      123
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      43
    term
    Asthenia
Complete source fields
description
All-Cause Mortality was assessed as per ITT population. Adverse Events: Safety Analysis Set included all participants who received at least one dose of study treatment.
event Groups
  1. deaths Num Affected
    99
    deaths Num At Risk
    126
    description
    Participants received AG-120 500 mg, tablet, orally, once daily (QD) in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up, or the sponsor ended the study for up to approximately 45 months.
    id
    EG000
    other Num Affected
    118
    other Num At Risk
    123
    serious Num Affected
    43
    serious Num At Risk
    123
    title
    AG-120
  2. deaths Num Affected
    14
    deaths Num At Risk
    61
    description
    Participants received AG-120 matched placebo, orally, QD in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up or the sponsor ended the study for up to approximately 7 months. Participants who experienced disease progression and received placebo were allowed to cross over and receive AG-120.
    id
    EG001
    other Num Affected
    56
    other Num At Risk
    59
    serious Num Affected
    14
    serious Num At Risk
    59
    title
    Placebo
  3. deaths Num Affected
    34
    deaths Num At Risk
    43
    description
    Participants who experienced disease progression and received placebo were allowed to cross over to receive AG-120 500 mg, tablet, orally, QD in each 28-day treatment cycle for up to approximately 32 months.
    id
    EG002
    other Num Affected
    36
    other Num At Risk
    43
    serious Num Affected
    12
    serious Num At Risk
    43
    title
    After Cross Over to AG-120
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      52
      num At Risk
      123
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      43
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      123
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      43
    term
    Diarrhoea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      123
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      43
    term
    Fatigue
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      123
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      43
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      123
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      43
    term
    Cough
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      123
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      43
    term
    Decreased appetite
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      123
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      43
    term
    Ascites
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      123
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      43
    term
    Vomiting
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      123
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      43
    term
    Anaemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      123
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      43
    term
    Oedema peripheral
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      123
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      43
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      123
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      43
    term
    Asthenia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      123
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      43
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      123
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      43
    term
    Tachyarrhythmia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      123
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      43
    term
    Vertigo
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      123
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      43
    term
    Abdominal distension
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      123
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      43
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      123
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      43
    term
    Abdominal pain lower
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      123
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      43
    term
    Ascites
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      123
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      43
    term
    Dysphagia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      123
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      43
    term
    Gastrointestinal haemorrhage
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      123
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      43
    term
    Intestinal obstruction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      123
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      43
    term
    Intestinal pseudo-obstruction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      123
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      43
    term
    Large intestinal obstruction
time Frame
From first dose of study drug up to 28 days after last dose for each intervention (Up to approximately 4 years)

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Preserved source evidence · Not medical advice