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NCT01802632 · ADVERSE EVENTS

Adverse events

AZD9291 First Time In Patients Ascending Dose Study · Source last updated 2026-04-20

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
AEs from start of study drug until 28 days post study treatment discontinuation, up to approximately 25 months (at time of analysis).
Other-event reporting threshold
5%

Different cohorts started at different times and so some cohorts have collected AE data for a shorter length of time, e.g. Extension cohort was the last cohort and follow up is approximately 12 months at time of analysis. Systematic assessment due to regular investigator assessment at study visits.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
AZD9291 80mg Extension

Phase II dose extension cohort in pre-treated EGFR T790M mutation positive patients in AZD9291 80mg tablet.

41 / 201191 / 201Not reported / Not reported
Dose Escalation

Pre-treated patient cohort in doses 20, 40, 80, 160 and 240mg AZD9291 capsule.

9 / 3131 / 31Not reported / Not reported
Dose Expansion

Pre-treated EGFR T790M mutation positive (by central testing) patient cohort. Dose groups were expanded to include more patients.

78 / 271265 / 271Not reported / Not reported
First Line

Cohort of patients receiving first-line treatment for EGFRm advanced NSCLC, in 80mg and 160mg AZD9291 capsule.

14 / 6060 / 60Not reported / Not reported
80mg Tablet

US-only cohort of pre-treated EGFR patients receiving the tablet formulation of AZD9291 (80 mg).

4 / 1212 / 12Not reported / Not reported
Japan Cytology

Japan-only cohort of patients (EGFR T790M mutation status determined from cytology samples) receiving AZD9291 80 mg tablet.

4 / 2824 / 28Not reported / Not reported

Group identifiers: EG000: AZD9291 80mg Extension · EG001: Dose Escalation · EG002: Dose Expansion · EG003: First Line · EG004: 80mg Tablet · EG005: Japan Cytology

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 18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      201
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      271
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      60
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      201
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      271
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      60
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Disseminated intravascular coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      201
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      271
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      60
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      201
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      271
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      60
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Cardiac failure congestive
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      201
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      271
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      60
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      201
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
      num Events
      1
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      271
      num Events
      4
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      60
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      201
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      271
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      60
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Inguinal hernia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      201
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      31
      num Events
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      271
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      60
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      201
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      271
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      60
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      201
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      271
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      60
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Asthenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      201
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      271
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      60
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      201
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      271
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      60
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Localised oedema

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 18.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      201
      num Events
      22
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      31
      num Events
      7
    3. group Id
      EG002
      num Affected
      36
      num At Risk
      271
      num Events
      49
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      60
      num Events
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      28
      num Events
      5
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      201
      num Events
      14
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      31
      num Events
      3
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      271
      num Events
      21
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      60
      num Events
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Dry eye
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      201
      num Events
      13
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      31
      num Events
      3
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      271
      num Events
      26
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      60
      num Events
      9
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Abdominal pain upper
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      201
      num Events
      31
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      31
      num Events
      4
    3. group Id
      EG002
      num Affected
      60
      num At Risk
      271
      num Events
      65
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      60
      num Events
      11
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      12
      num Events
      1
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      28
      num Events
      2
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      93
      num At Risk
      201
      num Events
      147
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      31
      num Events
      38
    3. group Id
      EG002
      num Affected
      144
      num At Risk
      271
      num Events
      219
    4. group Id
      EG003
      num Affected
      41
      num At Risk
      60
      num Events
      62
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      12
      num Events
      6
    6. group Id
      EG005
      num Affected
      9
      num At Risk
      28
      num Events
      9
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      201
      num Events
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
      num Events
      1
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      271
      num Events
      18
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      60
      num Events
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Dry mouth
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      201
      num Events
      45
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      31
      num Events
      9
    3. group Id
      EG002
      num Affected
      72
      num At Risk
      271
      num Events
      96
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      60
      num Events
      18
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      12
      num Events
      5
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      28
      num Events
      3
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      201
      num Events
      28
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      31
      num Events
      14
    3. group Id
      EG002
      num Affected
      50
      num At Risk
      271
      num Events
      63
    4. group Id
      EG003
      num Affected
      23
      num At Risk
      60
      num Events
      36
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      12
      num Events
      1
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      28
      num Events
      5
    term
    Stomatitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      201
      num Events
      31
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      31
      num Events
      10
    3. group Id
      EG002
      num Affected
      48
      num At Risk
      271
      num Events
      73
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      60
      num Events
      13
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      12
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      201
      num Events
      34
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      31
      num Events
      3
    3. group Id
      EG002
      num Affected
      25
      num At Risk
      271
      num Events
      36
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      60
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      12
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Asthenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      201
      num Events
      27
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      31
      num Events
      6
    3. group Id
      EG002
      num Affected
      64
      num At Risk
      271
      num Events
      68
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      60
      num Events
      16
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      12
      num Events
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      201
      num Events
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      271
      num Events
      22
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      60
      num Events
      3
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      12
      num Events
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Oedema peripheral
Complete source fields
description
Different cohorts started at different times and so some cohorts have collected AE data for a shorter length of time, e.g. Extension cohort was the last cohort and follow up is approximately 12 months at time of analysis. Systematic assessment due to regular investigator assessment at study visits.
event Groups
  1. description
    Phase II dose extension cohort in pre-treated EGFR T790M mutation positive patients in AZD9291 80mg tablet.
    id
    EG000
    other Num Affected
    191
    other Num At Risk
    201
    serious Num Affected
    41
    serious Num At Risk
    201
    title
    AZD9291 80mg Extension
  2. description
    Pre-treated patient cohort in doses 20, 40, 80, 160 and 240mg AZD9291 capsule.
    id
    EG001
    other Num Affected
    31
    other Num At Risk
    31
    serious Num Affected
    9
    serious Num At Risk
    31
    title
    Dose Escalation
  3. description
    Pre-treated EGFR T790M mutation positive (by central testing) patient cohort. Dose groups were expanded to include more patients.
    id
    EG002
    other Num Affected
    265
    other Num At Risk
    271
    serious Num Affected
    78
    serious Num At Risk
    271
    title
    Dose Expansion
  4. description
    Cohort of patients receiving first-line treatment for EGFRm advanced NSCLC, in 80mg and 160mg AZD9291 capsule.
    id
    EG003
    other Num Affected
    60
    other Num At Risk
    60
    serious Num Affected
    14
    serious Num At Risk
    60
    title
    First Line
  5. description
    US-only cohort of pre-treated EGFR patients receiving the tablet formulation of AZD9291 (80 mg).
    id
    EG004
    other Num Affected
    12
    other Num At Risk
    12
    serious Num Affected
    4
    serious Num At Risk
    12
    title
    80mg Tablet
  6. description
    Japan-only cohort of patients (EGFR T790M mutation status determined from cytology samples) receiving AZD9291 80 mg tablet.
    id
    EG005
    other Num Affected
    24
    other Num At Risk
    28
    serious Num Affected
    4
    serious Num At Risk
    28
    title
    Japan Cytology
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      201
      num Events
      22
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      31
      num Events
      7
    3. group Id
      EG002
      num Affected
      36
      num At Risk
      271
      num Events
      49
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      60
      num Events
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      28
      num Events
      5
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      201
      num Events
      14
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      31
      num Events
      3
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      271
      num Events
      21
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      60
      num Events
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Dry eye
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      201
      num Events
      13
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      31
      num Events
      3
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      271
      num Events
      26
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      60
      num Events
      9
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Abdominal pain upper
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      201
      num Events
      31
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      31
      num Events
      4
    3. group Id
      EG002
      num Affected
      60
      num At Risk
      271
      num Events
      65
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      60
      num Events
      11
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      12
      num Events
      1
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      28
      num Events
      2
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      93
      num At Risk
      201
      num Events
      147
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      31
      num Events
      38
    3. group Id
      EG002
      num Affected
      144
      num At Risk
      271
      num Events
      219
    4. group Id
      EG003
      num Affected
      41
      num At Risk
      60
      num Events
      62
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      12
      num Events
      6
    6. group Id
      EG005
      num Affected
      9
      num At Risk
      28
      num Events
      9
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      201
      num Events
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
      num Events
      1
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      271
      num Events
      18
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      60
      num Events
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Dry mouth
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      201
      num Events
      45
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      31
      num Events
      9
    3. group Id
      EG002
      num Affected
      72
      num At Risk
      271
      num Events
      96
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      60
      num Events
      18
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      12
      num Events
      5
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      28
      num Events
      3
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      201
      num Events
      28
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      31
      num Events
      14
    3. group Id
      EG002
      num Affected
      50
      num At Risk
      271
      num Events
      63
    4. group Id
      EG003
      num Affected
      23
      num At Risk
      60
      num Events
      36
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      12
      num Events
      1
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      28
      num Events
      5
    term
    Stomatitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      201
      num Events
      31
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      31
      num Events
      10
    3. group Id
      EG002
      num Affected
      48
      num At Risk
      271
      num Events
      73
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      60
      num Events
      13
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      12
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      201
      num Events
      34
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      31
      num Events
      3
    3. group Id
      EG002
      num Affected
      25
      num At Risk
      271
      num Events
      36
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      60
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      12
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Asthenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      201
      num Events
      27
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      31
      num Events
      6
    3. group Id
      EG002
      num Affected
      64
      num At Risk
      271
      num Events
      68
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      60
      num Events
      16
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      12
      num Events
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      201
      num Events
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      271
      num Events
      22
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      60
      num Events
      3
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      12
      num Events
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Oedema peripheral
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      201
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      271
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      60
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      201
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      271
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      60
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Disseminated intravascular coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      201
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      271
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      60
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      201
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      271
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      60
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Cardiac failure congestive
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      201
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      271
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      60
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      201
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
      num Events
      1
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      271
      num Events
      4
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      60
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      201
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      271
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      60
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Inguinal hernia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      201
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      31
      num Events
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      271
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      60
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      201
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      271
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      60
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      201
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      271
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      60
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Asthenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      201
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      271
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      60
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      201
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      271
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      60
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Localised oedema
time Frame
AEs from start of study drug until 28 days post study treatment discontinuation, up to approximately 25 months (at time of analysis).

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