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NCT04035486 · ADVERSE EVENTS

Adverse events

A Study of Osimertinib With or Without Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer (FLAURA2) · Source last updated 2026-09-03

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
Includes treatment emergent adverse events with onset date on or after the date of first dose and up to and including 28 days following discontinuation of treatment but prior to the start of a new anti-cancer therapy. For the Safety Run-In treatment arms, this was up to 45 months, or the data cut-off. For the Randomized treatment arms, this was up to 33 months, or the data cut-off.
Other-event reporting threshold
5%

All AE data is based off of the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment. The All-Cause Mortality section is based off of all subjects who were assigned a study treatment in either the Safety Run-In or Randomized Treatment Arms.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Safety Run-In: AZD9291 + Carboplatin + Pemetrexed

Osimertinib (AZD9291) 80 mg once daily (QD) with Carboplatin (AUC of 5 mg/mL/min \[AUC5\]) and Pemetrexed (500 mg/m2), both administered every 3 weeks (Q3W) for 4 cycles, followed by Osimertinib 80 mg once daily plus Pemetrexed maintenance (500 mg/m2) Q3W

5 / 1515 / 156 / 15
Safety Run-In: AZD9291 + Cisplatin + Pemetrexed

Osimertinib (AZD9291) 80 mg once daily (QD) with Cisplatin (75 mg/m2) and Pemetrexed (500 mg/m2), both administered every 3 weeks (Q3W) for 4 cycles, followed by Osimertinib 80 mg once daily plus Pemetrexed maintenance (500 mg/m2) Q3W

6 / 1514 / 153 / 15
Randomized: AZD9291 + Chemo

Osimertinib (AZD9291) 80 mg in combination with pemetrexed (500 mg/m2) plus either cisplatin (75 mg/m2) or carboplatin (AUC5) on Day 1 of 21-day cycles for 4 cycles, followed by Osimertinib (AZD9291) 80 mg QD with Pemetrexed maintenance (500 mg/m2) Q3W

104 / 276273 / 27671 / 279
Randomized: AZD9291

Osimertinib (AZD9291) 80mg QD.

53 / 275258 / 27578 / 278

Group identifiers: EG000: Safety Run-In: AZD9291 + Carboplatin + Pemetrexed · EG001: Safety Run-In: AZD9291 + Cisplatin + Pemetrexed · EG002: Randomized: AZD9291 + Chemo · EG003: Randomized: AZD9291

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
    Eye disorders
    source Vocabulary
    MedDRA version 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      276
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      275
      num Events
      0
    term
    Retinal tear
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      276
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      275
      num Events
      1
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      276
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      275
      num Events
      0
    term
    Myelosuppression
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      276
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      275
      num Events
      0
    term
    Colitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      276
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      275
      num Events
      1
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      276
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      275
      num Events
      0
    term
    Diverticular perforation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      276
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      275
      num Events
      0
    term
    Food poisoning
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      276
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      275
      num Events
      0
    term
    Gastritis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      276
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      275
      num Events
      0
    term
    Neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      276
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      275
      num Events
      0
    term
    Gastrointestinal haemorrhage
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      276
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      275
      num Events
      0
    term
    Gastrooesophageal reflux disease
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      276
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      275
      num Events
      0
    term
    Inguinal hernia

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
    Eye disorders
    source Vocabulary
    MedDRA version 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      276
      num Events
      18
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      275
      num Events
      1
    term
    Lacrimation increased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      276
      num Events
      10
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      275
      num Events
      3
    term
    Abdominal distension
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 25.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      15
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      276
      num Events
      16
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      275
      num Events
      7
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      276
      num Events
      22
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      275
      num Events
      8
    term
    Abdominal pain upper
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      276
      num Events
      1
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      275
      num Events
      3
    term
    Angular cheilitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      276
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      275
      num Events
      1
    term
    Aphthous ulcer
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      276
      num Events
      2
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      275
      num Events
      3
    term
    Cheilitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 25.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      15
      num Events
      16
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      15
      num Events
      5
    3. group Id
      EG002
      num Affected
      81
      num At Risk
      276
      num Events
      95
    4. group Id
      EG003
      num Affected
      28
      num At Risk
      275
      num Events
      30
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      276
      num Events
      8
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      275
      num Events
      2
    term
    Dental caries
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 25.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      15
      num Events
      13
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      15
      num Events
      6
    3. group Id
      EG002
      num Affected
      118
      num At Risk
      276
      num Events
      225
    4. group Id
      EG003
      num Affected
      112
      num At Risk
      275
      num Events
      160
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      276
      num Events
      16
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      275
      num Events
      4
    term
    Dry mouth
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      276
      num Events
      13
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      275
      num Events
      6
    term
    Dyspepsia
Complete source fields
description
All AE data is based off of the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment. The All-Cause Mortality section is based off of all subjects who were assigned a study treatment in either the Safety Run-In or Randomized Treatment Arms.
event Groups
  1. deaths Num Affected
    6
    deaths Num At Risk
    15
    description
    Osimertinib (AZD9291) 80 mg once daily (QD) with Carboplatin (AUC of 5 mg/mL/min \[AUC5\]) and Pemetrexed (500 mg/m2), both administered every 3 weeks (Q3W) for 4 cycles, followed by Osimertinib 80 mg once daily plus Pemetrexed maintenance (500 mg/m2) Q3W
    id
    EG000
    other Num Affected
    15
    other Num At Risk
    15
    serious Num Affected
    5
    serious Num At Risk
    15
    title
    Safety Run-In: AZD9291 + Carboplatin + Pemetrexed
  2. deaths Num Affected
    3
    deaths Num At Risk
    15
    description
    Osimertinib (AZD9291) 80 mg once daily (QD) with Cisplatin (75 mg/m2) and Pemetrexed (500 mg/m2), both administered every 3 weeks (Q3W) for 4 cycles, followed by Osimertinib 80 mg once daily plus Pemetrexed maintenance (500 mg/m2) Q3W
    id
    EG001
    other Num Affected
    14
    other Num At Risk
    15
    serious Num Affected
    6
    serious Num At Risk
    15
    title
    Safety Run-In: AZD9291 + Cisplatin + Pemetrexed
  3. deaths Num Affected
    71
    deaths Num At Risk
    279
    description
    Osimertinib (AZD9291) 80 mg in combination with pemetrexed (500 mg/m2) plus either cisplatin (75 mg/m2) or carboplatin (AUC5) on Day 1 of 21-day cycles for 4 cycles, followed by Osimertinib (AZD9291) 80 mg QD with Pemetrexed maintenance (500 mg/m2) Q3W
    id
    EG002
    other Num Affected
    273
    other Num At Risk
    276
    serious Num Affected
    104
    serious Num At Risk
    276
    title
    Randomized: AZD9291 + Chemo
  4. deaths Num Affected
    78
    deaths Num At Risk
    278
    description
    Osimertinib (AZD9291) 80mg QD.
    id
    EG003
    other Num Affected
    258
    other Num At Risk
    275
    serious Num Affected
    53
    serious Num At Risk
    275
    title
    Randomized: AZD9291
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA version 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      276
      num Events
      18
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      275
      num Events
      1
    term
    Lacrimation increased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      276
      num Events
      10
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      275
      num Events
      3
    term
    Abdominal distension
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 25.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      15
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      276
      num Events
      16
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      275
      num Events
      7
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      276
      num Events
      22
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      275
      num Events
      8
    term
    Abdominal pain upper
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      276
      num Events
      1
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      275
      num Events
      3
    term
    Angular cheilitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      276
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      275
      num Events
      1
    term
    Aphthous ulcer
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      276
      num Events
      2
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      275
      num Events
      3
    term
    Cheilitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 25.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      15
      num Events
      16
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      15
      num Events
      5
    3. group Id
      EG002
      num Affected
      81
      num At Risk
      276
      num Events
      95
    4. group Id
      EG003
      num Affected
      28
      num At Risk
      275
      num Events
      30
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      276
      num Events
      8
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      275
      num Events
      2
    term
    Dental caries
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 25.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      15
      num Events
      13
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      15
      num Events
      6
    3. group Id
      EG002
      num Affected
      118
      num At Risk
      276
      num Events
      225
    4. group Id
      EG003
      num Affected
      112
      num At Risk
      275
      num Events
      160
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      276
      num Events
      16
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      275
      num Events
      4
    term
    Dry mouth
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      276
      num Events
      13
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      275
      num Events
      6
    term
    Dyspepsia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA version 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      276
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      275
      num Events
      0
    term
    Retinal tear
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      276
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      275
      num Events
      1
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      276
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      275
      num Events
      0
    term
    Myelosuppression
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      276
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      275
      num Events
      0
    term
    Colitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      276
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      275
      num Events
      1
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      276
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      275
      num Events
      0
    term
    Diverticular perforation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      276
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      275
      num Events
      0
    term
    Food poisoning
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      276
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      275
      num Events
      0
    term
    Gastritis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      276
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      275
      num Events
      0
    term
    Neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      276
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      275
      num Events
      0
    term
    Gastrointestinal haemorrhage
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      276
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      275
      num Events
      0
    term
    Gastrooesophageal reflux disease
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      276
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      275
      num Events
      0
    term
    Inguinal hernia
time Frame
Includes treatment emergent adverse events with onset date on or after the date of first dose and up to and including 28 days following discontinuation of treatment but prior to the start of a new anti-cancer therapy. For the Safety Run-In treatment arms, this was up to 45 months, or the data cut-off. For the Randomized treatment arms, this was up to 33 months, or the data cut-off.

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Preserved source evidence · Not medical advice