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NCT02702414 · ADVERSE EVENTS

Adverse events

Study of Pembrolizumab (MK-3475) as Monotherapy in Participants With Advanced Hepatocellular Carcinoma (MK-3475-224/KEYNOTE-224) · Source last updated 2024-09-04

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
Up to approximately 87 months
Other-event reporting threshold
5%

All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort 1: Hepatocellular Carcinoma (HCC)-Prior Systemic Therapy With Sorafenib-First Course

Participants with previously systemically treated HCC received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.

44 / 10496 / 10494 / 105
Cohort 2: HCC-Systemic Therapy Naïve-First Course

Participants with HCC who had not received treatment for systemic disease received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.

21 / 5146 / 5142 / 51
Cohort 1: Hepatocellular Carcinoma (HCC)-Prior Systemic Therapy With Sorafenib-Second Course

Participants from Cohort 1 who met the criteria for re-treatment received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 17 administrations.

0 / 44 / 42 / 4
Cohort 2: HCC-Systemic Therapy Naïve-Second Course

Participants from Cohort 2 who met the criteria for re-treatment received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 17 administrations.

0 / 10 / 10 / 1

Group identifiers: EG000: Cohort 1: Hepatocellular Carcinoma (HCC)-Prior Systemic Therapy With Sorafenib-First Course · EG001: Cohort 2: HCC-Systemic Therapy Naïve-First Course · EG002: Cohort 1: Hepatocellular Carcinoma (HCC)-Prior Systemic Therapy With Sorafenib-Second Course · EG003: Cohort 2: HCC-Systemic Therapy Naïve-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 26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      104
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      51
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      104
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      51
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Acute myocardial infarction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      104
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Atrioventricular block second degree
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      104
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Cardiac failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      104
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      51
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Cardiogenic shock
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      104
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      51
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Chronic left ventricular failure
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      104
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Myocarditis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      104
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Ventricular fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      104
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      51
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Adrenal insufficiency
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      104
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Hypophysitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      104
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      51
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Retinal vein occlusion
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      104
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Abdominal pain

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 26.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      104
      num Events
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      4
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      104
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      51
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Atrial fibrillation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      104
      num Events
      9
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      51
      num Events
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Hypothyroidism
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      104
      num Events
      18
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      51
      num Events
      9
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      104
      num Events
      13
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      51
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Abdominal pain upper
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      104
      num Events
      12
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      51
      num Events
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Ascites
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      104
      num Events
      18
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      51
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      104
      num Events
      21
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      51
      num Events
      15
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      104
      num Events
      5
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      51
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Dry mouth
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      104
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      51
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Dyspepsia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      104
      num Events
      21
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      51
      num Events
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      104
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      51
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Varices oesophageal
Complete source fields
description
All-cause mortality (ACM)=all allocated participants; AEs=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. Per protocol, collection of AEs and ACM were planned for both first and second courses and reported separately.
event Groups
  1. deaths Num Affected
    94
    deaths Num At Risk
    105
    description
    Participants with previously systemically treated HCC received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.
    id
    EG000
    other Num Affected
    96
    other Num At Risk
    104
    serious Num Affected
    44
    serious Num At Risk
    104
    title
    Cohort 1: Hepatocellular Carcinoma (HCC)-Prior Systemic Therapy With Sorafenib-First Course
  2. deaths Num Affected
    42
    deaths Num At Risk
    51
    description
    Participants with HCC who had not received treatment for systemic disease received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.
    id
    EG001
    other Num Affected
    46
    other Num At Risk
    51
    serious Num Affected
    21
    serious Num At Risk
    51
    title
    Cohort 2: HCC-Systemic Therapy Naïve-First Course
  3. deaths Num Affected
    2
    deaths Num At Risk
    4
    description
    Participants from Cohort 1 who met the criteria for re-treatment received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 17 administrations.
    id
    EG002
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    0
    serious Num At Risk
    4
    title
    Cohort 1: Hepatocellular Carcinoma (HCC)-Prior Systemic Therapy With Sorafenib-Second Course
  4. deaths Num Affected
    0
    deaths Num At Risk
    1
    description
    Participants from Cohort 2 who met the criteria for re-treatment received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 17 administrations.
    id
    EG003
    other Num Affected
    0
    other Num At Risk
    1
    serious Num Affected
    0
    serious Num At Risk
    1
    title
    Cohort 2: HCC-Systemic Therapy Naïve-Second Course
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      104
      num Events
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      4
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      104
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      51
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Atrial fibrillation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      104
      num Events
      9
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      51
      num Events
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Hypothyroidism
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      104
      num Events
      18
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      51
      num Events
      9
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      104
      num Events
      13
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      51
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Abdominal pain upper
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      104
      num Events
      12
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      51
      num Events
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Ascites
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      104
      num Events
      18
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      51
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      104
      num Events
      21
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      51
      num Events
      15
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      104
      num Events
      5
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      51
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Dry mouth
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      104
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      51
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Dyspepsia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      104
      num Events
      21
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      51
      num Events
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      104
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      51
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Varices oesophageal
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      104
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      51
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      104
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      51
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Acute myocardial infarction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      104
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Atrioventricular block second degree
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      104
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Cardiac failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      104
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      51
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Cardiogenic shock
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      104
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      51
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Chronic left ventricular failure
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      104
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Myocarditis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      104
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Ventricular fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      104
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      51
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Adrenal insufficiency
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      104
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Hypophysitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      104
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      51
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Retinal vein occlusion
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      104
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      51
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Abdominal pain
time Frame
Up to approximately 87 months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice