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NCT02435433 · ADVERSE EVENTS

Adverse events

A Study of Ramucirumab (LY3009806) Versus Placebo in Participants With Hepatocellular Carcinoma and Elevated Baseline Alpha-Fetoprotein · Source last updated 2023-01-20

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
Baseline up to 3.2 years
Other-event reporting threshold
5%

All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Ramucirumab + BSC

8 milligrams per kilogram (mg/kg) ramucirumab administered as an intravenous (IV) injection on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.

72 / 197189 / 197162 / 197
Placebo+BSC

Placebo administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met. Participants still on treatment at the time of study completion may have the option to crossover to the ramucirumab arm.

27 / 9577 / 9576 / 95
Open Label Ramucirumab + BSC

8 mg/kg ramucirumab administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.

18 / 4740 / 4733 / 47
Ramucirumab MEE Cohort

8 mg/kg ramucirumab administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.

10 / 3939 / 3935 / 39
Placebo MEE Cohort

Placebo administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met. Participants still on treatment at the time of study completion may have the option to crossover to the ramucirumab arm.

3 / 2117 / 2118 / 21

Group identifiers: EG000: Ramucirumab + BSC · EG001: Placebo+BSC · EG002: Open Label Ramucirumab + BSC · EG003: Ramucirumab MEE Cohort · EG004: Placebo MEE Cohort

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 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      197
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      95
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      47
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      39
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      197
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      95
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      47
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      39
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      197
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      95
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      47
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      39
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Splenic infarction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      197
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      95
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      47
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      39
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Acute coronary syndrome
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      197
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      95
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      47
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      39
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Angina pectoris
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      197
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      95
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      47
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      39
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Cardiac arrest
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      197
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      95
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      47
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      39
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Myocardial infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      197
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      95
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      47
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      39
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Abdominal hernia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      197
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      95
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      47
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      39
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      197
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      95
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      47
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      39
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Abdominal pain upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      197
      num Events
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      95
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      47
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      39
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Ascites
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      197
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      95
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      47
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      39
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Colitis

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 25.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      197
      num Events
      28
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      95
      num Events
      7
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      47
      num Events
      5
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      39
      num Events
      13
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      21
      num Events
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      197
      num Events
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      95
      num Events
      1
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      47
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      39
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      197
      num Events
      18
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      95
      num Events
      6
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      47
      num Events
      4
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      39
      num Events
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      21
      num Events
      1
    term
    Abdominal distension
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      197
      num Events
      46
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      95
      num Events
      16
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      47
      num Events
      4
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      39
      num Events
      10
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      21
      num Events
      2
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      197
      num Events
      10
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      95
      num Events
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      47
      num Events
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      39
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      21
      num Events
      1
    term
    Abdominal pain upper
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      197
      num Events
      47
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      95
      num Events
      7
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      47
      num Events
      6
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      39
      num Events
      8
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      21
      num Events
      2
    term
    Ascites
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      197
      num Events
      33
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      95
      num Events
      19
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      47
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      39
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      21
      num Events
      1
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      197
      num Events
      46
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      95
      num Events
      18
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      47
      num Events
      13
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      39
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      197
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      95
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      47
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      39
      num Events
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Mouth haemorrhage
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      197
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      95
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      47
      num Events
      0
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      39
      num Events
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Mouth ulceration
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      197
      num Events
      47
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      95
      num Events
      12
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      47
      num Events
      6
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      39
      num Events
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      21
      num Events
      2
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      197
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      95
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      47
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      39
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Upper gastrointestinal haemorrhage
Complete source fields
description
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
event Groups
  1. deaths Num Affected
    162
    deaths Num At Risk
    197
    description
    8 milligrams per kilogram (mg/kg) ramucirumab administered as an intravenous (IV) injection on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.
    id
    EG000
    other Num Affected
    189
    other Num At Risk
    197
    serious Num Affected
    72
    serious Num At Risk
    197
    title
    Ramucirumab + BSC
  2. deaths Num Affected
    76
    deaths Num At Risk
    95
    description
    Placebo administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met. Participants still on treatment at the time of study completion may have the option to crossover to the ramucirumab arm.
    id
    EG001
    other Num Affected
    77
    other Num At Risk
    95
    serious Num Affected
    27
    serious Num At Risk
    95
    title
    Placebo+BSC
  3. deaths Num Affected
    33
    deaths Num At Risk
    47
    description
    8 mg/kg ramucirumab administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.
    id
    EG002
    other Num Affected
    40
    other Num At Risk
    47
    serious Num Affected
    18
    serious Num At Risk
    47
    title
    Open Label Ramucirumab + BSC
  4. deaths Num Affected
    35
    deaths Num At Risk
    39
    description
    8 mg/kg ramucirumab administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.
    id
    EG003
    other Num Affected
    39
    other Num At Risk
    39
    serious Num Affected
    10
    serious Num At Risk
    39
    title
    Ramucirumab MEE Cohort
  5. deaths Num Affected
    18
    deaths Num At Risk
    21
    description
    Placebo administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met. Participants still on treatment at the time of study completion may have the option to crossover to the ramucirumab arm.
    id
    EG004
    other Num Affected
    17
    other Num At Risk
    21
    serious Num Affected
    3
    serious Num At Risk
    21
    title
    Placebo MEE Cohort
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      197
      num Events
      28
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      95
      num Events
      7
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      47
      num Events
      5
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      39
      num Events
      13
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      21
      num Events
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      197
      num Events
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      95
      num Events
      1
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      47
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      39
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      197
      num Events
      18
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      95
      num Events
      6
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      47
      num Events
      4
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      39
      num Events
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      21
      num Events
      1
    term
    Abdominal distension
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      197
      num Events
      46
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      95
      num Events
      16
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      47
      num Events
      4
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      39
      num Events
      10
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      21
      num Events
      2
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      197
      num Events
      10
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      95
      num Events
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      47
      num Events
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      39
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      21
      num Events
      1
    term
    Abdominal pain upper
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      197
      num Events
      47
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      95
      num Events
      7
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      47
      num Events
      6
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      39
      num Events
      8
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      21
      num Events
      2
    term
    Ascites
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      197
      num Events
      33
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      95
      num Events
      19
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      47
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      39
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      21
      num Events
      1
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      197
      num Events
      46
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      95
      num Events
      18
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      47
      num Events
      13
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      39
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      197
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      95
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      47
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      39
      num Events
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Mouth haemorrhage
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      197
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      95
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      47
      num Events
      0
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      39
      num Events
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Mouth ulceration
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      197
      num Events
      47
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      95
      num Events
      12
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      47
      num Events
      6
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      39
      num Events
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      21
      num Events
      2
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      197
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      95
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      47
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      39
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Upper gastrointestinal haemorrhage
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      197
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      95
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      47
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      39
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      197
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      95
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      47
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      39
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      197
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      95
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      47
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      39
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Splenic infarction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      197
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      95
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      47
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      39
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Acute coronary syndrome
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      197
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      95
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      47
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      39
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Angina pectoris
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      197
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      95
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      47
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      39
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Cardiac arrest
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      197
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      95
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      47
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      39
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Myocardial infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      197
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      95
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      47
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      39
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Abdominal hernia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      197
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      95
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      47
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      39
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      197
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      95
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      47
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      39
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Abdominal pain upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      197
      num Events
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      95
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      47
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      39
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Ascites
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      197
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      95
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      47
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      39
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Colitis
time Frame
Baseline up to 3.2 years

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Preserved source evidence · Not medical advice