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NCT03062358 · ADVERSE EVENTS

Adverse events

Study of Pembrolizumab (MK-3475) or Placebo Given With Best Supportive Care in Asian Participants With Previously Treated Advanced Hepatocellular Carcinoma (MK-3475-394/KEYNOTE-394) · Source last updated 2025-09-30

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

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

Collection time frame
All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
Other-event reporting threshold
5%

All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Pembrolizumab First Course

Participants received 200 mg pembrolizumab by intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.

76 / 299272 / 299263 / 300
Placebo First Course

Participants received placebo by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.

31 / 153135 / 153146 / 153
Pembrolizumab Second Course

Eligible participants randomized to the pembrolizumab first course who stopped pembrolizumab with stable disease (SD) or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year

1 / 1212 / 128 / 12

Group identifiers: EG000: Pembrolizumab First Course · EG001: Placebo First Course · EG002: Pembrolizumab Second Course

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 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      299
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      153
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      299
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      153
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Acute myocardial infarction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      299
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      153
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Coronary artery disease
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      299
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      153
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Prinzmetal angina
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      299
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      153
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Hypophysitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      299
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      153
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      299
      num Events
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Ascites
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      299
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      153
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      299
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      153
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Gastritis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      299
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Gastritis haemorrhagic
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      299
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Gastroduodenal ulcer
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      299
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Gastrointestinal haemorrhage

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 27.1
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      299
      num Events
      55
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      153
      num Events
      17
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
      num Events
      2
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      299
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      153
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Bradycardia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      299
      num Events
      16
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      153
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Hyperthyroidism
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      299
      num Events
      35
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      153
      num Events
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Hypothyroidism
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      299
      num Events
      18
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      153
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Abdominal distension
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      299
      num Events
      26
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      153
      num Events
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      299
      num Events
      20
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      153
      num Events
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Abdominal pain upper
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      299
      num Events
      16
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      153
      num Events
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Ascites
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      299
      num Events
      29
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      153
      num Events
      14
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      299
      num Events
      76
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      153
      num Events
      20
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      299
      num Events
      7
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      153
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Dyspepsia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      299
      num Events
      24
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      153
      num Events
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Nausea
Complete source fields
description
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
event Groups
  1. deaths Num Affected
    263
    deaths Num At Risk
    300
    description
    Participants received 200 mg pembrolizumab by intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.
    id
    EG000
    other Num Affected
    272
    other Num At Risk
    299
    serious Num Affected
    76
    serious Num At Risk
    299
    title
    Pembrolizumab First Course
  2. deaths Num Affected
    146
    deaths Num At Risk
    153
    description
    Participants received placebo by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.
    id
    EG001
    other Num Affected
    135
    other Num At Risk
    153
    serious Num Affected
    31
    serious Num At Risk
    153
    title
    Placebo First Course
  3. deaths Num Affected
    8
    deaths Num At Risk
    12
    description
    Eligible participants randomized to the pembrolizumab first course who stopped pembrolizumab with stable disease (SD) or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year
    id
    EG002
    other Num Affected
    12
    other Num At Risk
    12
    serious Num Affected
    1
    serious Num At Risk
    12
    title
    Pembrolizumab Second Course
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      299
      num Events
      55
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      153
      num Events
      17
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
      num Events
      2
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      299
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      153
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Bradycardia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      299
      num Events
      16
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      153
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Hyperthyroidism
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      299
      num Events
      35
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      153
      num Events
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Hypothyroidism
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      299
      num Events
      18
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      153
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Abdominal distension
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      299
      num Events
      26
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      153
      num Events
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      299
      num Events
      20
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      153
      num Events
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Abdominal pain upper
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      299
      num Events
      16
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      153
      num Events
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Ascites
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      299
      num Events
      29
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      153
      num Events
      14
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      299
      num Events
      76
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      153
      num Events
      20
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      299
      num Events
      7
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      153
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Dyspepsia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      299
      num Events
      24
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      153
      num Events
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Nausea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      299
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      153
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      299
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      153
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Acute myocardial infarction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      299
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      153
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Coronary artery disease
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      299
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      153
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Prinzmetal angina
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      299
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      153
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Hypophysitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      299
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      153
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      299
      num Events
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Ascites
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      299
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      153
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      299
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      153
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Gastritis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      299
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Gastritis haemorrhagic
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      299
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Gastroduodenal ulcer
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      299
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Gastrointestinal haemorrhage
time Frame
All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.

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Preserved source evidence · Not medical advice