Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02327078 · ADVERSE EVENTS

Adverse events

A Study of the Safety, Tolerability, and Efficacy of Epacadostat Administered in Combination With Nivolumab in Select Advanced Cancers (ECHO-204) · Source last updated 2025-08-14

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
up to approximately 39 months for Phase 1 and up to approximately 35 months for Phase 2
Other-event reporting threshold
5%

The safety population includes all subjects enrolled in the study who received at least 1 dose of study drug .

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Phase 1, Part 1: Epacadostat 25 mg + Nivolumab 3 mg

Participants received epacadostat 25 mg, orally, BID in combination of nivolumab 3 mg/kg, IV, on Days 1, 15, 29, and 43 of each 8-week cycle.

0 / 33 / 32 / 3
Phase 1, Part 1: Epacadostat 50 mg + Nivolumab 3 mg

Participants received epacadostat 50 mg, orally, BID in combination of nivolumab 3 mg/kg, IV, Q3W, on Days 1, 15, 29, and 43 of each 8-week cycle.

3 / 66 / 64 / 6
Phase 1, Part 1: Epacadostat 100 mg + Nivolumab 3 mg

Participants received epacadostat 100 mg, orally, BID in combination of nivolumab 3 mg/kg, IV, Q3W, on Days 1, 15, 29, and 43 of each 8-week cycle.

4 / 1414 / 1411 / 14
Phase 1, Part 1: Epacadostat 300 mg + Nivolumab 3 mg

Participants received epacadostat 300 mg, orally, BID in combination of nivolumab 3 mg/kg, IV, Q3W, on Days 1, 15, 29, and 43 of each 8-week cycle.

4 / 1313 / 137 / 13
Phase 1, Part 2: Epacadostat 100 mg + Nivolumab 360 mg + 5-FU/Platinum

Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 360 mg, IV, Q2W, on Day 1 of each 21-day cycle along with 5-FU/Platinum chemotherapy regimen IV. Participants were de-escalated to epacadostat 50 mg BID if 100 mg was not tolerated.

4 / 66 / 64 / 6
Phase 1, Part 2: Epacadostat 100 mg + Nivolumab 360 mg + Pemetrexed/ Platinum

Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 360 mg, IV, Q2W, on Day 1 of each 21-day cycle along with Pemetrexed /Platinum chemotherapy regimen IV. Participants were de-escalated to epacadostat 50 mg BID if 100 mg was not tolerated.

2 / 33 / 33 / 3
Phase 1, Part 2: Epacadostat 100 mg + Nivolumab 360 mg + Paclitaxel/ Platinum

Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 360 mg, IV, Q2W, on Day 1 of each 21-day cycle along with Paclitaxel/Platinum chemotherapy regimen IV. Participants were de-escalated to epacadostat 50 mg BID if 100 mg was not tolerated

2 / 33 / 32 / 3
Phase 2: Epacadostat 100 mg + Nivolumab 240/480 mg

Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 and participants with melanoma I/O-relapsed and melanoma I/O-refractory enrolled in this arm received epacadostat 100 mg BID in combination with nivolumab 480 mg IV infusion Q4W on Days 1 and Day 29 of each 8-week cycle.

40 / 8381 / 8352 / 83
Phase 2: Epacadostat 300 mg + Nivolumab 240 mg

Participants with select solid tumor types received epacadostat 300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.

89 / 176173 / 17697 / 176
Total

Total

148 / 307302 / 307182 / 307

Group identifiers: EG000: Phase 1, Part 1: Epacadostat 25 mg + Nivolumab 3 mg · EG001: Phase 1, Part 1: Epacadostat 50 mg + Nivolumab 3 mg · EG002: Phase 1, Part 1: Epacadostat 100 mg + Nivolumab 3 mg · EG003: Phase 1, Part 1: Epacadostat 300 mg + Nivolumab 3 mg · EG004: Phase 1, Part 2: Epacadostat 100 mg + Nivolumab 360 mg + 5-FU/Platinum · EG005: Phase 1, Part 2: Epacadostat 100 mg + Nivolumab 360 mg + Pemetrexed/ Platinum · EG006: Phase 1, Part 2: Epacadostat 100 mg + Nivolumab 360 mg + Paclitaxel/ Platinum · EG007: Phase 2: Epacadostat 100 mg + Nivolumab 240/480 mg · EG008: Phase 2: Epacadostat 300 mg + Nivolumab 240 mg · EG009: 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
    Infections and infestations
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      83
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      176
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      307
      num Events
      1
    term
    Abdominal infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      83
      num Events
      0
    9. group Id
      EG008
      num Affected
      4
      num At Risk
      176
      num Events
      4
    10. group Id
      EG009
      num Affected
      4
      num At Risk
      307
      num Events
      4
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      83
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      176
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      307
      num Events
      1
    term
    Acute myocardial infarction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      83
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      176
      num Events
      1
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      307
      num Events
      1
    term
    Acute respiratory failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      83
      num Events
      0
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      176
      num Events
      2
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      307
      num Events
      3
    term
    Adrenal insufficiency
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      83
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      176
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      307
      num Events
      1
    term
    Adrenocortical insufficiency acute
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      83
      num Events
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      176
      num Events
      0
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      307
      num Events
      2
    term
    Anaemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      83
      num Events
      1
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      176
      num Events
      1
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      307
      num Events
      2
    term
    Aphasia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      83
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      176
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      307
      num Events
      1
    term
    Arterial haemorrhage
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      83
      num Events
      3
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      176
      num Events
      1
    10. group Id
      EG009
      num Affected
      4
      num At Risk
      307
      num Events
      4
    term
    Ascites
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      83
      num Events
      2
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      176
      num Events
      2
    10. group Id
      EG009
      num Affected
      5
      num At Risk
      307
      num Events
      5
    term
    Asthenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      83
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      176
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      307
      num Events
      1
    term
    Atrial fibrillation

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 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      14
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      6
      num At Risk
      83
      num Events
      6
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      176
      num Events
      2
    10. group Id
      EG009
      num Affected
      13
      num At Risk
      307
      num Events
      13
    term
    Abdominal distension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      14
      num Events
      5
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      13
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      14
      num At Risk
      83
      num Events
      19
    9. group Id
      EG008
      num Affected
      18
      num At Risk
      176
      num Events
      20
    10. group Id
      EG009
      num Affected
      43
      num At Risk
      307
      num Events
      50
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      83
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      176
      num Events
      0
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      307
      num Events
      2
    term
    Abdominal pain lower
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      14
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      83
      num Events
      3
    9. group Id
      EG008
      num Affected
      7
      num At Risk
      176
      num Events
      7
    10. group Id
      EG009
      num Affected
      12
      num At Risk
      307
      num Events
      12
    term
    Abdominal pain upper
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      83
      num Events
      0
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      176
      num Events
      2
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      307
      num Events
      3
    term
    Acute respiratory failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      83
      num Events
      1
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      176
      num Events
      2
    10. group Id
      EG009
      num Affected
      4
      num At Risk
      307
      num Events
      4
    term
    Agitation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      13
      num Events
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      12
      num At Risk
      83
      num Events
      17
    9. group Id
      EG008
      num Affected
      37
      num At Risk
      176
      num Events
      51
    10. group Id
      EG009
      num Affected
      53
      num At Risk
      307
      num Events
      73
    term
    Alanine aminotransferase increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      3
      num Events
      2
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      83
      num Events
      4
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      176
      num Events
      2
    10. group Id
      EG009
      num Affected
      8
      num At Risk
      307
      num Events
      9
    term
    Alopecia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      13
      num Events
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      9
      num At Risk
      83
      num Events
      15
    9. group Id
      EG008
      num Affected
      16
      num At Risk
      176
      num Events
      21
    10. group Id
      EG009
      num Affected
      29
      num At Risk
      307
      num Events
      43
    term
    Amylase increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      14
      num Events
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      13
      num Events
      2
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      6
      num Events
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
      num Events
      2
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      3
      num Events
      2
    8. group Id
      EG007
      num Affected
      17
      num At Risk
      83
      num Events
      22
    9. group Id
      EG008
      num Affected
      30
      num At Risk
      176
      num Events
      42
    10. group Id
      EG009
      num Affected
      62
      num At Risk
      307
      num Events
      80
    term
    Anaemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      83
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      176
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      307
      num Events
      1
    term
    Animal bite
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      83
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      176
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      307
      num Events
      1
    term
    Anorectal discomfort
Complete source fields
description
The safety population includes all subjects enrolled in the study who received at least 1 dose of study drug .
event Groups
  1. deaths Num Affected
    2
    deaths Num At Risk
    3
    description
    Participants received epacadostat 25 mg, orally, BID in combination of nivolumab 3 mg/kg, IV, on Days 1, 15, 29, and 43 of each 8-week cycle.
    id
    EG000
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    Phase 1, Part 1: Epacadostat 25 mg + Nivolumab 3 mg
  2. deaths Num Affected
    4
    deaths Num At Risk
    6
    description
    Participants received epacadostat 50 mg, orally, BID in combination of nivolumab 3 mg/kg, IV, Q3W, on Days 1, 15, 29, and 43 of each 8-week cycle.
    id
    EG001
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    3
    serious Num At Risk
    6
    title
    Phase 1, Part 1: Epacadostat 50 mg + Nivolumab 3 mg
  3. deaths Num Affected
    11
    deaths Num At Risk
    14
    description
    Participants received epacadostat 100 mg, orally, BID in combination of nivolumab 3 mg/kg, IV, Q3W, on Days 1, 15, 29, and 43 of each 8-week cycle.
    id
    EG002
    other Num Affected
    14
    other Num At Risk
    14
    serious Num Affected
    4
    serious Num At Risk
    14
    title
    Phase 1, Part 1: Epacadostat 100 mg + Nivolumab 3 mg
  4. deaths Num Affected
    7
    deaths Num At Risk
    13
    description
    Participants received epacadostat 300 mg, orally, BID in combination of nivolumab 3 mg/kg, IV, Q3W, on Days 1, 15, 29, and 43 of each 8-week cycle.
    id
    EG003
    other Num Affected
    13
    other Num At Risk
    13
    serious Num Affected
    4
    serious Num At Risk
    13
    title
    Phase 1, Part 1: Epacadostat 300 mg + Nivolumab 3 mg
  5. deaths Num Affected
    4
    deaths Num At Risk
    6
    description
    Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 360 mg, IV, Q2W, on Day 1 of each 21-day cycle along with 5-FU/Platinum chemotherapy regimen IV. Participants were de-escalated to epacadostat 50 mg BID if 100 mg was not tolerated.
    id
    EG004
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    4
    serious Num At Risk
    6
    title
    Phase 1, Part 2: Epacadostat 100 mg + Nivolumab 360 mg + 5-FU/Platinum
  6. deaths Num Affected
    3
    deaths Num At Risk
    3
    description
    Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 360 mg, IV, Q2W, on Day 1 of each 21-day cycle along with Pemetrexed /Platinum chemotherapy regimen IV. Participants were de-escalated to epacadostat 50 mg BID if 100 mg was not tolerated.
    id
    EG005
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    2
    serious Num At Risk
    3
    title
    Phase 1, Part 2: Epacadostat 100 mg + Nivolumab 360 mg + Pemetrexed/ Platinum
  7. deaths Num Affected
    2
    deaths Num At Risk
    3
    description
    Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 360 mg, IV, Q2W, on Day 1 of each 21-day cycle along with Paclitaxel/Platinum chemotherapy regimen IV. Participants were de-escalated to epacadostat 50 mg BID if 100 mg was not tolerated
    id
    EG006
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    2
    serious Num At Risk
    3
    title
    Phase 1, Part 2: Epacadostat 100 mg + Nivolumab 360 mg + Paclitaxel/ Platinum
  8. deaths Num Affected
    52
    deaths Num At Risk
    83
    description
    Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 and participants with melanoma I/O-relapsed and melanoma I/O-refractory enrolled in this arm received epacadostat 100 mg BID in combination with nivolumab 480 mg IV infusion Q4W on Days 1 and Day 29 of each 8-week cycle.
    id
    EG007
    other Num Affected
    81
    other Num At Risk
    83
    serious Num Affected
    40
    serious Num At Risk
    83
    title
    Phase 2: Epacadostat 100 mg + Nivolumab 240/480 mg
  9. deaths Num Affected
    97
    deaths Num At Risk
    176
    description
    Participants with select solid tumor types received epacadostat 300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
    id
    EG008
    other Num Affected
    173
    other Num At Risk
    176
    serious Num Affected
    89
    serious Num At Risk
    176
    title
    Phase 2: Epacadostat 300 mg + Nivolumab 240 mg
  10. deaths Num Affected
    182
    deaths Num At Risk
    307
    description
    Total
    id
    EG009
    other Num Affected
    302
    other Num At Risk
    307
    serious Num Affected
    148
    serious Num At Risk
    307
    title
    Total
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      14
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      6
      num At Risk
      83
      num Events
      6
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      176
      num Events
      2
    10. group Id
      EG009
      num Affected
      13
      num At Risk
      307
      num Events
      13
    term
    Abdominal distension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      14
      num Events
      5
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      13
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      14
      num At Risk
      83
      num Events
      19
    9. group Id
      EG008
      num Affected
      18
      num At Risk
      176
      num Events
      20
    10. group Id
      EG009
      num Affected
      43
      num At Risk
      307
      num Events
      50
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      83
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      176
      num Events
      0
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      307
      num Events
      2
    term
    Abdominal pain lower
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      14
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      83
      num Events
      3
    9. group Id
      EG008
      num Affected
      7
      num At Risk
      176
      num Events
      7
    10. group Id
      EG009
      num Affected
      12
      num At Risk
      307
      num Events
      12
    term
    Abdominal pain upper
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      83
      num Events
      0
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      176
      num Events
      2
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      307
      num Events
      3
    term
    Acute respiratory failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      83
      num Events
      1
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      176
      num Events
      2
    10. group Id
      EG009
      num Affected
      4
      num At Risk
      307
      num Events
      4
    term
    Agitation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      13
      num Events
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      12
      num At Risk
      83
      num Events
      17
    9. group Id
      EG008
      num Affected
      37
      num At Risk
      176
      num Events
      51
    10. group Id
      EG009
      num Affected
      53
      num At Risk
      307
      num Events
      73
    term
    Alanine aminotransferase increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      3
      num Events
      2
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      83
      num Events
      4
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      176
      num Events
      2
    10. group Id
      EG009
      num Affected
      8
      num At Risk
      307
      num Events
      9
    term
    Alopecia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      13
      num Events
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      9
      num At Risk
      83
      num Events
      15
    9. group Id
      EG008
      num Affected
      16
      num At Risk
      176
      num Events
      21
    10. group Id
      EG009
      num Affected
      29
      num At Risk
      307
      num Events
      43
    term
    Amylase increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      14
      num Events
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      13
      num Events
      2
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      6
      num Events
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
      num Events
      2
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      3
      num Events
      2
    8. group Id
      EG007
      num Affected
      17
      num At Risk
      83
      num Events
      22
    9. group Id
      EG008
      num Affected
      30
      num At Risk
      176
      num Events
      42
    10. group Id
      EG009
      num Affected
      62
      num At Risk
      307
      num Events
      80
    term
    Anaemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      83
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      176
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      307
      num Events
      1
    term
    Animal bite
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      83
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      176
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      307
      num Events
      1
    term
    Anorectal discomfort
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      83
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      176
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      307
      num Events
      1
    term
    Abdominal infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      83
      num Events
      0
    9. group Id
      EG008
      num Affected
      4
      num At Risk
      176
      num Events
      4
    10. group Id
      EG009
      num Affected
      4
      num At Risk
      307
      num Events
      4
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      83
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      176
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      307
      num Events
      1
    term
    Acute myocardial infarction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      83
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      176
      num Events
      1
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      307
      num Events
      1
    term
    Acute respiratory failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      83
      num Events
      0
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      176
      num Events
      2
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      307
      num Events
      3
    term
    Adrenal insufficiency
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      83
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      176
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      307
      num Events
      1
    term
    Adrenocortical insufficiency acute
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      83
      num Events
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      176
      num Events
      0
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      307
      num Events
      2
    term
    Anaemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      83
      num Events
      1
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      176
      num Events
      1
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      307
      num Events
      2
    term
    Aphasia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      83
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      176
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      307
      num Events
      1
    term
    Arterial haemorrhage
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      83
      num Events
      3
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      176
      num Events
      1
    10. group Id
      EG009
      num Affected
      4
      num At Risk
      307
      num Events
      4
    term
    Ascites
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      83
      num Events
      2
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      176
      num Events
      2
    10. group Id
      EG009
      num Affected
      5
      num At Risk
      307
      num Events
      5
    term
    Asthenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      83
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      176
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      307
      num Events
      1
    term
    Atrial fibrillation
time Frame
up to approximately 39 months for Phase 1 and up to approximately 35 months for Phase 2

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

Preserved source evidence · Not medical advice