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NCT02460198 · ADVERSE EVENTS

Adverse events

Study of Pembrolizumab (MK-3475) as Monotherapy in Participants With Previously-Treated Locally Advanced Unresectable or Metastatic Colorectal Cancer (MK-3475-164/KEYNOTE-164) · Source last updated 2023-07-27

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 66 months
Other-event reporting threshold
5%

Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021

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

Participants were previously treated with standard therapies, which must include fluoropyrimidine, oxaliplatin, and irinotecan. Cohort A participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to approximately 35 cycles (up to approximately 2 years).

31 / 6156 / 6138 / 61
Cohort B First Course

Participants were previously treated with at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan +/ - anti vascular endothelial growth factor (VEGF)/ epidermal growth factor regulator (EGFR) monoclonal antibody. Cohort B participants received pembrolizumab 200 mg IV on Day 1 Q3W for up to approximately 35 cycles (up to approximately 2 years).

25 / 6358 / 6331 / 63
Cohort A Second Course

Participants who completed first course of treatment were treated with pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to 17 cycles (approximately 1 year) after experiencing PD if criteria were met for re-treatment.

1 / 65 / 60 / 6
Cohort B Second Course

Participants who completed first course of treatment were treated with pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to 17 cycles (approximately 1 year) after experiencing PD if criteria were met for re-treatment.

1 / 33 / 30 / 3

Group identifiers: EG000: Cohort A First Course · EG001: Cohort B First Course · EG002: Cohort A Second Course · EG003: Cohort B 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 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      63
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      63
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      61
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      63
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Acute myocardial infarction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      61
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      63
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Sinus bradycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      63
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Cataract
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      63
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Corneal decompensation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      63
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Rhegmatogenous retinal detachment
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      61
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      63
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      61
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      63
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Abdominal pain upper
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      61
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      63
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Colitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      63
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      61
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      63
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Duodenal ulcer

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 23.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      61
      num Events
      21
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      63
      num Events
      13
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      61
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      63
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    term
    Tinnitus
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      61
      num Events
      5
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      63
      num Events
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Hyperthyroidism
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      61
      num Events
      6
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      63
      num Events
      15
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Hypothyroidism
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      61
      num Events
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      63
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Dry eye
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      63
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    term
    Ocular discomfort
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      61
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      63
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Abdominal discomfort
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      61
      num Events
      4
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      63
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Abdominal distension
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      61
      num Events
      26
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      63
      num Events
      18
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      63
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    term
    Angular cheilitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      61
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      63
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Colitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      61
      num Events
      15
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      63
      num Events
      14
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Constipation
Complete source fields
description
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
event Groups
  1. deaths Num Affected
    38
    deaths Num At Risk
    61
    description
    Participants were previously treated with standard therapies, which must include fluoropyrimidine, oxaliplatin, and irinotecan. Cohort A participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to approximately 35 cycles (up to approximately 2 years).
    id
    EG000
    other Num Affected
    56
    other Num At Risk
    61
    serious Num Affected
    31
    serious Num At Risk
    61
    title
    Cohort A First Course
  2. deaths Num Affected
    31
    deaths Num At Risk
    63
    description
    Participants were previously treated with at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan +/ - anti vascular endothelial growth factor (VEGF)/ epidermal growth factor regulator (EGFR) monoclonal antibody. Cohort B participants received pembrolizumab 200 mg IV on Day 1 Q3W for up to approximately 35 cycles (up to approximately 2 years).
    id
    EG001
    other Num Affected
    58
    other Num At Risk
    63
    serious Num Affected
    25
    serious Num At Risk
    63
    title
    Cohort B First Course
  3. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    Participants who completed first course of treatment were treated with pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to 17 cycles (approximately 1 year) after experiencing PD if criteria were met for re-treatment.
    id
    EG002
    other Num Affected
    5
    other Num At Risk
    6
    serious Num Affected
    1
    serious Num At Risk
    6
    title
    Cohort A Second Course
  4. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Participants who completed first course of treatment were treated with pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to 17 cycles (approximately 1 year) after experiencing PD if criteria were met for re-treatment.
    id
    EG003
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    Cohort B Second Course
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      61
      num Events
      21
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      63
      num Events
      13
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      61
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      63
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    term
    Tinnitus
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      61
      num Events
      5
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      63
      num Events
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Hyperthyroidism
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      61
      num Events
      6
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      63
      num Events
      15
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Hypothyroidism
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      61
      num Events
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      63
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Dry eye
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      63
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    term
    Ocular discomfort
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      61
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      63
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Abdominal discomfort
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      61
      num Events
      4
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      63
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Abdominal distension
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      61
      num Events
      26
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      63
      num Events
      18
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      63
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    term
    Angular cheilitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      61
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      63
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Colitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      61
      num Events
      15
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      63
      num Events
      14
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Constipation
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      63
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      63
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      61
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      63
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Acute myocardial infarction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      61
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      63
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Sinus bradycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      63
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Cataract
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      63
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Corneal decompensation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      63
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Rhegmatogenous retinal detachment
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      61
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      63
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      61
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      63
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Abdominal pain upper
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      61
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      63
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Colitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      63
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      61
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      63
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Duodenal ulcer
time Frame
Up to approximately 66 months

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

Preserved source evidence · Independent clinical review pending · Not medical advice