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NCT02178722 · ADVERSE EVENTS

Adverse events

Study to Explore the Safety, Tolerability and Efficacy of MK-3475 in Combination With INCB024360 in Participants With Selected Cancers · Source last updated 2022-02-14

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
Approximately 54 months
Other-event reporting threshold
5%

The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Phase 1: Epacadostat 25 mg BID

Epacadostat 25 mg tablet orally twice daily (BID) starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.

0 / 44 / 42 / 4
Phase 1: Epacadostat 50 MG BID

Epacadostat 50 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.

8 / 2018 / 2013 / 20
Phase 1: Epacadostat 100 MG BID

Epacadostat 100 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1

9 / 1817 / 1812 / 18
Phase 1: Epacadostat 300 MG BID

Epacadostat 300 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1

9 / 2020 / 2014 / 20
Phase 2: Epacadostat 100 MG BID

Epacadostat 100 mg tablet orally BID in combination with pembrolizumab 200 mg intravenously every 3 weeks (Q3W).

195 / 382375 / 382209 / 382
Total

Total

221 / 444434 / 444250 / 444

Group identifiers: EG000: Phase 1: Epacadostat 25 mg BID · EG001: Phase 1: Epacadostat 50 MG BID · EG002: Phase 1: Epacadostat 100 MG BID · EG003: Phase 1: Epacadostat 300 MG BID · EG004: Phase 2: Epacadostat 100 MG BID · EG005: Total

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      382
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      444
      num Events
      1
    term
    Abdominal distension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      20
      num Events
      1
    5. group Id
      EG004
      num Affected
      12
      num At Risk
      382
      num Events
      13
    6. group Id
      EG005
      num Affected
      14
      num At Risk
      444
      num Events
      15
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      382
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      444
      num Events
      1
    term
    Abdominal pain upper
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      382
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      444
      num Events
      1
    term
    Acute coronary syndrome
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      382
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      444
      num Events
      1
    term
    Acute hepatic failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      382
      num Events
      8
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      444
      num Events
      8
    term
    Acute kidney injury
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      382
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      444
      num Events
      1
    term
    Acute myocardial infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      382
      num Events
      6
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      444
      num Events
      6
    term
    Acute respiratory failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      382
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      444
      num Events
      1
    term
    Adult failure to thrive
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      382
      num Events
      5
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      444
      num Events
      6
    term
    Anaemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      382
      num Events
      2
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      444
      num Events
      3
    term
    Anxiety
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      382
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      444
      num Events
      1
    term
    Aphasia

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      11
      num At Risk
      382
      num Events
      12
    6. group Id
      EG005
      num Affected
      12
      num At Risk
      444
      num Events
      13
    term
    Abdominal discomfort
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      20
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      20
      num Events
      3
    5. group Id
      EG004
      num Affected
      19
      num At Risk
      382
      num Events
      19
    6. group Id
      EG005
      num Affected
      25
      num At Risk
      444
      num Events
      25
    term
    Abdominal distension
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      18
      num Events
      3
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      20
      num Events
      4
    5. group Id
      EG004
      num Affected
      53
      num At Risk
      382
      num Events
      60
    6. group Id
      EG005
      num Affected
      59
      num At Risk
      444
      num Events
      68
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      20
      num Events
      1
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      382
      num Events
      6
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      444
      num Events
      7
    term
    Abdominal pain lower
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      23
      num At Risk
      382
      num Events
      25
    6. group Id
      EG005
      num Affected
      25
      num At Risk
      444
      num Events
      27
    term
    Abdominal pain upper
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      382
      num Events
      1
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      444
      num Events
      2
    term
    Actinic keratosis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      382
      num Events
      7
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      444
      num Events
      9
    term
    Acute kidney injury
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      382
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      444
      num Events
      1
    term
    Acute sinusitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      20
      num Events
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      18
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      20
      num Events
      1
    5. group Id
      EG004
      num Affected
      36
      num At Risk
      382
      num Events
      46
    6. group Id
      EG005
      num Affected
      42
      num At Risk
      444
      num Events
      54
    term
    Alanine aminotransferase increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      20
      num Events
      1
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      382
      num Events
      6
    6. group Id
      EG005
      num Affected
      9
      num At Risk
      444
      num Events
      9
    term
    Alopecia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      382
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      444
      num Events
      1
    term
    Alopecia areata
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      382
      num Events
      2
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      444
      num Events
      3
    term
    Amnesia
Complete source fields
description
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
event Groups
  1. deaths Num Affected
    2
    deaths Num At Risk
    4
    description
    Epacadostat 25 mg tablet orally twice daily (BID) starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
    id
    EG000
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    0
    serious Num At Risk
    4
    title
    Phase 1: Epacadostat 25 mg BID
  2. deaths Num Affected
    13
    deaths Num At Risk
    20
    description
    Epacadostat 50 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
    id
    EG001
    other Num Affected
    18
    other Num At Risk
    20
    serious Num Affected
    8
    serious Num At Risk
    20
    title
    Phase 1: Epacadostat 50 MG BID
  3. deaths Num Affected
    12
    deaths Num At Risk
    18
    description
    Epacadostat 100 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1
    id
    EG002
    other Num Affected
    17
    other Num At Risk
    18
    serious Num Affected
    9
    serious Num At Risk
    18
    title
    Phase 1: Epacadostat 100 MG BID
  4. deaths Num Affected
    14
    deaths Num At Risk
    20
    description
    Epacadostat 300 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1
    id
    EG003
    other Num Affected
    20
    other Num At Risk
    20
    serious Num Affected
    9
    serious Num At Risk
    20
    title
    Phase 1: Epacadostat 300 MG BID
  5. deaths Num Affected
    209
    deaths Num At Risk
    382
    description
    Epacadostat 100 mg tablet orally BID in combination with pembrolizumab 200 mg intravenously every 3 weeks (Q3W).
    id
    EG004
    other Num Affected
    375
    other Num At Risk
    382
    serious Num Affected
    195
    serious Num At Risk
    382
    title
    Phase 2: Epacadostat 100 MG BID
  6. deaths Num Affected
    250
    deaths Num At Risk
    444
    description
    Total
    id
    EG005
    other Num Affected
    434
    other Num At Risk
    444
    serious Num Affected
    221
    serious Num At Risk
    444
    title
    Total
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      11
      num At Risk
      382
      num Events
      12
    6. group Id
      EG005
      num Affected
      12
      num At Risk
      444
      num Events
      13
    term
    Abdominal discomfort
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      20
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      20
      num Events
      3
    5. group Id
      EG004
      num Affected
      19
      num At Risk
      382
      num Events
      19
    6. group Id
      EG005
      num Affected
      25
      num At Risk
      444
      num Events
      25
    term
    Abdominal distension
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      18
      num Events
      3
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      20
      num Events
      4
    5. group Id
      EG004
      num Affected
      53
      num At Risk
      382
      num Events
      60
    6. group Id
      EG005
      num Affected
      59
      num At Risk
      444
      num Events
      68
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      20
      num Events
      1
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      382
      num Events
      6
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      444
      num Events
      7
    term
    Abdominal pain lower
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      23
      num At Risk
      382
      num Events
      25
    6. group Id
      EG005
      num Affected
      25
      num At Risk
      444
      num Events
      27
    term
    Abdominal pain upper
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      382
      num Events
      1
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      444
      num Events
      2
    term
    Actinic keratosis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      382
      num Events
      7
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      444
      num Events
      9
    term
    Acute kidney injury
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      382
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      444
      num Events
      1
    term
    Acute sinusitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      20
      num Events
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      18
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      20
      num Events
      1
    5. group Id
      EG004
      num Affected
      36
      num At Risk
      382
      num Events
      46
    6. group Id
      EG005
      num Affected
      42
      num At Risk
      444
      num Events
      54
    term
    Alanine aminotransferase increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      20
      num Events
      1
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      382
      num Events
      6
    6. group Id
      EG005
      num Affected
      9
      num At Risk
      444
      num Events
      9
    term
    Alopecia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      382
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      444
      num Events
      1
    term
    Alopecia areata
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      382
      num Events
      2
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      444
      num Events
      3
    term
    Amnesia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      382
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      444
      num Events
      1
    term
    Abdominal distension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      20
      num Events
      1
    5. group Id
      EG004
      num Affected
      12
      num At Risk
      382
      num Events
      13
    6. group Id
      EG005
      num Affected
      14
      num At Risk
      444
      num Events
      15
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      382
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      444
      num Events
      1
    term
    Abdominal pain upper
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      382
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      444
      num Events
      1
    term
    Acute coronary syndrome
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      382
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      444
      num Events
      1
    term
    Acute hepatic failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      382
      num Events
      8
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      444
      num Events
      8
    term
    Acute kidney injury
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      382
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      444
      num Events
      1
    term
    Acute myocardial infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      382
      num Events
      6
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      444
      num Events
      6
    term
    Acute respiratory failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      382
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      444
      num Events
      1
    term
    Adult failure to thrive
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      382
      num Events
      5
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      444
      num Events
      6
    term
    Anaemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      382
      num Events
      2
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      444
      num Events
      3
    term
    Anxiety
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      382
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      444
      num Events
      1
    term
    Aphasia
time Frame
Approximately 54 months

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice