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NCT03085914 · ADVERSE EVENTS

Adverse events

A Study of Epacadostat in Combination With Pembrolizumab and Chemotherapy in Participants With Advanced or Metastatic Solid Tumors (ECHO-207/KEYNOTE-723) · Source last updated 2022-09-23

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 21 months
Other-event reporting threshold
5%

The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Group A: Epa + Pembrolizumab + mFOLFOX6

Epacadostat (Epa) oral twice-daily (BID) continuous daily dosing at the protocol-defined dose in combination with pembrolizumab administered intravenously (IV) in combination with mFOLFOX6 (oxaliplatin IV + leucovorin IV + 5-fluorouracil (5-FU) IV.

5 / 99 / 96 / 9
Group B: Epa + Pembrolizumab + Nab-Paclitaxel and Gemcitabine

Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with nab-paclitaxel IV and gemcitabine IV.

5 / 98 / 96 / 9
Group C: Epa + Pembrolizumab + Paclitaxel and Carboplatin

Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) in combination with paclitaxel IV and carboplatin IV.

5 / 1111 / 114 / 11
Group D: Epa + Pembrolizumab + Pemetrexed and Platinum Agent

Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with pemetrexed IV and Investigator's choice of platinum agent: carboplatin IV or cisplatin IV.

3 / 99 / 91 / 9
Group E: Epa + Pembrolizumab + Cyclophosphamide

Epa (100 mg)oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with cyclophosphamide PO.

6 / 1313 / 136 / 13
Group F: Epa + Pembrolizumab + Gemcitabine and Platinum Agent

Epa oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab IV in combination with gemcitabine IV and Investigator's choice of platinum agent: carboplatin IV or cisplatin IV.

4 / 88 / 82 / 8
Group G: Epa + Pembrolizumab + 5-FU and Platinum Agent

Epa oral BID continuousdaily dosing at the protocol-defined dose in combination with pembrolizumab IV in combination with 5-FU IV and Investigator's choice of platinum agent: carboplatin IV or cisplatin IV.

6 / 1110 / 113 / 11
Total

Total

34 / 7068 / 7028 / 70

Group identifiers: EG000: Group A: Epa + Pembrolizumab + mFOLFOX6 · EG001: Group B: Epa + Pembrolizumab + Nab-Paclitaxel and Gemcitabine · EG002: Group C: Epa + Pembrolizumab + Paclitaxel and Carboplatin · EG003: Group D: Epa + Pembrolizumab + Pemetrexed and Platinum Agent · EG004: Group E: Epa + Pembrolizumab + Cyclophosphamide · EG005: Group F: Epa + Pembrolizumab + Gemcitabine and Platinum Agent · EG006: Group G: Epa + Pembrolizumab + 5-FU and Platinum Agent · EG007: 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 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      13
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      70
      num Events
      1
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      70
      num Events
      2
    term
    Acute kidney injury
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      70
      num Events
      2
    term
    Ammonia increased
  4. 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
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      13
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      70
      num Events
      2
    term
    Anaemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      8
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      70
      num Events
      3
    term
    Bile duct obstruction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      8
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      70
      num Events
      1
    term
    Catheter site cellulitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      70
      num Events
      1
    term
    Cellulitis
  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
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      70
      num Events
      1
    term
    Cerebrovascular accident
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      70
      num Events
      1
    term
    Cervix cancer metastatic
  10. 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
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      70
      num Events
      1
    term
    Cough
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      13
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      70
      num Events
      2
    term
    Death
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      11
      num Events
      1
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      70
      num Events
      1
    term
    Dehydration

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
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
      num Events
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      70
      num Events
      16
    term
    Abdominal discomfort
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      9
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      13
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      8
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      70
      num Events
      4
    term
    Abdominal distension
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      70
      num Events
      1
    term
    Abdominal hernia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      11
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      13
      num Events
      1
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      8
      num Events
      2
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      11
      num Events
      1
    8. group Id
      EG007
      num Affected
      8
      num At Risk
      70
      num Events
      9
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      70
      num Events
      1
    term
    Abdominal pain lower
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      13
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      11
      num Events
      1
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      70
      num Events
      4
    term
    Abdominal pain upper
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      70
      num Events
      1
    term
    Abnormal sensation in eye
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      13
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      70
      num Events
      1
    term
    Activated partial thromboplastin time prolonged
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      11
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      70
      num Events
      2
    term
    Adrenal insufficiency
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      70
      num Events
      1
    term
    Ageusia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      9
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      9
      num Events
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      11
      num Events
      3
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      9
      num Events
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      13
      num Events
      1
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      8
      num Events
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      11
      num Events
      1
    8. group Id
      EG007
      num Affected
      16
      num At Risk
      70
      num Events
      17
    term
    Alanine aminotransferase increased
  12. 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
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      9
      num Events
      2
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      11
      num Events
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      13
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      9
      num At Risk
      70
      num Events
      9
    term
    Alopecia
Complete source fields
description
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
event Groups
  1. deaths Num Affected
    6
    deaths Num At Risk
    9
    description
    Epacadostat (Epa) oral twice-daily (BID) continuous daily dosing at the protocol-defined dose in combination with pembrolizumab administered intravenously (IV) in combination with mFOLFOX6 (oxaliplatin IV + leucovorin IV + 5-fluorouracil (5-FU) IV.
    id
    EG000
    other Num Affected
    9
    other Num At Risk
    9
    serious Num Affected
    5
    serious Num At Risk
    9
    title
    Group A: Epa + Pembrolizumab + mFOLFOX6
  2. deaths Num Affected
    6
    deaths Num At Risk
    9
    description
    Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with nab-paclitaxel IV and gemcitabine IV.
    id
    EG001
    other Num Affected
    8
    other Num At Risk
    9
    serious Num Affected
    5
    serious Num At Risk
    9
    title
    Group B: Epa + Pembrolizumab + Nab-Paclitaxel and Gemcitabine
  3. deaths Num Affected
    4
    deaths Num At Risk
    11
    description
    Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) in combination with paclitaxel IV and carboplatin IV.
    id
    EG002
    other Num Affected
    11
    other Num At Risk
    11
    serious Num Affected
    5
    serious Num At Risk
    11
    title
    Group C: Epa + Pembrolizumab + Paclitaxel and Carboplatin
  4. deaths Num Affected
    1
    deaths Num At Risk
    9
    description
    Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with pemetrexed IV and Investigator's choice of platinum agent: carboplatin IV or cisplatin IV.
    id
    EG003
    other Num Affected
    9
    other Num At Risk
    9
    serious Num Affected
    3
    serious Num At Risk
    9
    title
    Group D: Epa + Pembrolizumab + Pemetrexed and Platinum Agent
  5. deaths Num Affected
    6
    deaths Num At Risk
    13
    description
    Epa (100 mg)oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with cyclophosphamide PO.
    id
    EG004
    other Num Affected
    13
    other Num At Risk
    13
    serious Num Affected
    6
    serious Num At Risk
    13
    title
    Group E: Epa + Pembrolizumab + Cyclophosphamide
  6. deaths Num Affected
    2
    deaths Num At Risk
    8
    description
    Epa oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab IV in combination with gemcitabine IV and Investigator's choice of platinum agent: carboplatin IV or cisplatin IV.
    id
    EG005
    other Num Affected
    8
    other Num At Risk
    8
    serious Num Affected
    4
    serious Num At Risk
    8
    title
    Group F: Epa + Pembrolizumab + Gemcitabine and Platinum Agent
  7. deaths Num Affected
    3
    deaths Num At Risk
    11
    description
    Epa oral BID continuousdaily dosing at the protocol-defined dose in combination with pembrolizumab IV in combination with 5-FU IV and Investigator's choice of platinum agent: carboplatin IV or cisplatin IV.
    id
    EG006
    other Num Affected
    10
    other Num At Risk
    11
    serious Num Affected
    6
    serious Num At Risk
    11
    title
    Group G: Epa + Pembrolizumab + 5-FU and Platinum Agent
  8. deaths Num Affected
    28
    deaths Num At Risk
    70
    description
    Total
    id
    EG007
    other Num Affected
    68
    other Num At Risk
    70
    serious Num Affected
    34
    serious Num At Risk
    70
    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
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
      num Events
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      70
      num Events
      16
    term
    Abdominal discomfort
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      9
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      13
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      8
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      70
      num Events
      4
    term
    Abdominal distension
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      70
      num Events
      1
    term
    Abdominal hernia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      11
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      13
      num Events
      1
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      8
      num Events
      2
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      11
      num Events
      1
    8. group Id
      EG007
      num Affected
      8
      num At Risk
      70
      num Events
      9
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      70
      num Events
      1
    term
    Abdominal pain lower
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      13
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      11
      num Events
      1
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      70
      num Events
      4
    term
    Abdominal pain upper
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      70
      num Events
      1
    term
    Abnormal sensation in eye
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      13
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      70
      num Events
      1
    term
    Activated partial thromboplastin time prolonged
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      11
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      70
      num Events
      2
    term
    Adrenal insufficiency
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      70
      num Events
      1
    term
    Ageusia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      9
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      9
      num Events
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      11
      num Events
      3
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      9
      num Events
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      13
      num Events
      1
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      8
      num Events
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      11
      num Events
      1
    8. group Id
      EG007
      num Affected
      16
      num At Risk
      70
      num Events
      17
    term
    Alanine aminotransferase increased
  12. 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
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      9
      num Events
      2
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      11
      num Events
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      13
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      9
      num At Risk
      70
      num Events
      9
    term
    Alopecia
serious 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
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      13
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      70
      num Events
      1
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      70
      num Events
      2
    term
    Acute kidney injury
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      70
      num Events
      2
    term
    Ammonia increased
  4. 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
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      13
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      70
      num Events
      2
    term
    Anaemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      8
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      70
      num Events
      3
    term
    Bile duct obstruction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      8
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      70
      num Events
      1
    term
    Catheter site cellulitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      70
      num Events
      1
    term
    Cellulitis
  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
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      70
      num Events
      1
    term
    Cerebrovascular accident
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      9
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      70
      num Events
      1
    term
    Cervix cancer metastatic
  10. 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
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      70
      num Events
      1
    term
    Cough
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      13
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      70
      num Events
      2
    term
    Death
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      9
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      13
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      11
      num Events
      1
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      70
      num Events
      1
    term
    Dehydration
time Frame
Up to 21 months

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Preserved source evidence · Not medical advice