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NCT03043313 · ADVERSE EVENTS

Adverse events

Tucatinib Plus Trastuzumab in Patients With HER2+ Colorectal Cancer · Source last updated 2024-11-26

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-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Other-event reporting threshold
2%

Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Tucatinib+Trastuzumab (Cohorts A+B)

Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Trastuzumab 8 mg/kg by IV infusion on Day 1 of Cycle 1 and 6 mg/kg on Day 1 of each subsequent cycle until PD, death, withdrawal of consent, study closure, or alternative therapy.

20 / 8682 / 8654 / 86
Tucatinib Pre-Crossover (Cohort C)

Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Participants who did not respond to monotherapy were given the option to receive tucatinib and trastuzumab based on radiographic progression (as determined by investigator assessment using RECIST v1.1), or if they had not achieved a PR or CR by the week 12 assessment.

3 / 3028 / 302 / 31
Tucatinib Post-Crossover (Cohort C)

Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Trastuzumab 8 mg/kg by IV infusion on Day 1 of Cycle 1 and 6 mg/kg on Day 1 of each subsequent cycle until PD, death, withdrawal of consent, study closure, or alternative therapy.

6 / 2823 / 2815 / 28

Group identifiers: EG000: Tucatinib+Trastuzumab (Cohorts A+B) · EG001: Tucatinib Pre-Crossover (Cohort C) · EG002: Tucatinib Post-Crossover (Cohort C)

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
    Cardiac disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    term
    Angina unstable
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
    term
    Cardiac failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    term
    Colitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    term
    Dyspepsia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    term
    Gastrointestinal obstruction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    term
    Large intestinal obstruction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    term
    Rectal perforation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    term
    Small intestinal obstruction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    term
    Fatigue

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 v26.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      28
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
    term
    Lacrimation increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
    term
    Abdominal discomfort
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
    term
    Abdominal distension
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
    term
    Abdominal pain lower
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
    term
    Abdominal pain upper
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      28
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
    term
    Flatulence
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
    term
    Oral pain
Complete source fields
description
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
event Groups
  1. deaths Num Affected
    54
    deaths Num At Risk
    86
    description
    Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Trastuzumab 8 mg/kg by IV infusion on Day 1 of Cycle 1 and 6 mg/kg on Day 1 of each subsequent cycle until PD, death, withdrawal of consent, study closure, or alternative therapy.
    id
    EG000
    other Num Affected
    82
    other Num At Risk
    86
    serious Num Affected
    20
    serious Num At Risk
    86
    title
    Tucatinib+Trastuzumab (Cohorts A+B)
  2. deaths Num Affected
    2
    deaths Num At Risk
    31
    description
    Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Participants who did not respond to monotherapy were given the option to receive tucatinib and trastuzumab based on radiographic progression (as determined by investigator assessment using RECIST v1.1), or if they had not achieved a PR or CR by the week 12 assessment.
    id
    EG001
    other Num Affected
    28
    other Num At Risk
    30
    serious Num Affected
    3
    serious Num At Risk
    30
    title
    Tucatinib Pre-Crossover (Cohort C)
  3. deaths Num Affected
    15
    deaths Num At Risk
    28
    description
    Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Trastuzumab 8 mg/kg by IV infusion on Day 1 of Cycle 1 and 6 mg/kg on Day 1 of each subsequent cycle until PD, death, withdrawal of consent, study closure, or alternative therapy.
    id
    EG002
    other Num Affected
    23
    other Num At Risk
    28
    serious Num Affected
    6
    serious Num At Risk
    28
    title
    Tucatinib Post-Crossover (Cohort C)
frequency Threshold
2
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      28
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
    term
    Lacrimation increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
    term
    Abdominal discomfort
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
    term
    Abdominal distension
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
    term
    Abdominal pain lower
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
    term
    Abdominal pain upper
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      28
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
    term
    Flatulence
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
    term
    Oral pain
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    term
    Angina unstable
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
    term
    Cardiac failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    term
    Colitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    term
    Dyspepsia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    term
    Gastrointestinal obstruction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    term
    Large intestinal obstruction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    term
    Rectal perforation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    term
    Small intestinal obstruction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    term
    Fatigue
time Frame
All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months

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Preserved source evidence · Not medical advice