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NCT03241173 · ADVERSE EVENTS

Adverse events

A Study Exploring the Safety and Efficacy of INCAGN01949 in Combination With Immune Therapies in Advanced or Metastatic Malignancies · Source last updated 2022-09-27

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
up to 17.4 months
Other-event reporting threshold
5%

Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Phase 1, Dose Escalation: INCAGN01949 70 mg + Nivolumab 240 mg

Participants with advanced or metastatic select solid tumors received INCAGN01949 70 milligrams (mg) every 2 weeks (Q2W) beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as intravenous (IV) infusions.

3 / 44 / 43 / 4
Phase 1, Dose Escalation: INCAGN01949 200 mg + Nivolumab 240 mg

Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.

1 / 44 / 42 / 4
Phase 1, Dose Escalation: INCAGN01949 350 mg + Nivolumab 240 mg

Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.

4 / 55 / 54 / 5
Phase 1, Dose Escalation: INCAGN01949 700 mg + Nivolumab 240 mg

Participants with advanced or metastatic select solid tumors received INCAGN01949 700 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.

3 / 55 / 54 / 5
Phase 1, Dose Escalation: INCAGN01949 70 mg + Ipilimumab 1 mg/kg

Participants with advanced or metastatic select solid tumors received INCAGN01949 70 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kilogram (kg) every 6 weeks (Q6W) beginning on Cycle 1 Day 1, administered as IV infusions.

2 / 44 / 42 / 4
Phase 1, Dose Escalation: INCAGN01949 200 mg + Ipilimumab 1 mg/kg

Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.

2 / 55 / 52 / 5
Phase 1, Dose Escalation: INCAGN01949 350 mg + Ipilimumab 1 mg/kg

Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.

2 / 44 / 43 / 4
Phase 1, Dose Escalation: INCAGN01949 700 mg + Ipilimumab 1 mg/kg

Participants with advanced or metastatic select solid tumors received INCAGN01949 700 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.

1 / 33 / 31 / 3
Phase 1, Safety Expansion: INCAGN01949 70 mg + Nivolumab 240 mg

Participants with advanced or metastatic select solid tumors received INCAGN01949 70 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.

4 / 66 / 65 / 6
Phase 1, Safety Expansion: INCAGN01949 200 mg + Nivolumab 240 mg

Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.

3 / 66 / 64 / 6
Phase 1, Safety Expansion: INCAGN01949 350 mg + Nivolumab 240 mg

Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.

3 / 66 / 63 / 6
Total

Total

28 / 5252 / 5233 / 52

Group identifiers: EG000: Phase 1, Dose Escalation: INCAGN01949 70 mg + Nivolumab 240 mg · EG001: Phase 1, Dose Escalation: INCAGN01949 200 mg + Nivolumab 240 mg · EG002: Phase 1, Dose Escalation: INCAGN01949 350 mg + Nivolumab 240 mg · EG003: Phase 1, Dose Escalation: INCAGN01949 700 mg + Nivolumab 240 mg · EG004: Phase 1, Dose Escalation: INCAGN01949 70 mg + Ipilimumab 1 mg/kg · EG005: Phase 1, Dose Escalation: INCAGN01949 200 mg + Ipilimumab 1 mg/kg · EG006: Phase 1, Dose Escalation: INCAGN01949 350 mg + Ipilimumab 1 mg/kg · EG007: Phase 1, Dose Escalation: INCAGN01949 700 mg + Ipilimumab 1 mg/kg · EG008: Phase 1, Safety Expansion: INCAGN01949 70 mg + Nivolumab 240 mg · EG009: Phase 1, Safety Expansion: INCAGN01949 200 mg + Nivolumab 240 mg · EG010: Phase 1, Safety Expansion: INCAGN01949 350 mg + Nivolumab 240 mg · EG011: 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
    Endocrine disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Adrenal insufficiency
  2. 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
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      6
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      5
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Cholangitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      6
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Cholestasis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Coronary artery disease
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      6
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Death
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Dehydration
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      5
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Dermatitis contact
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      5
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Dysphagia
  11. 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
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
      num Events
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      52
      num Events
      3
    term
    Dyspnoea
  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
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Failure to thrive

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
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      52
      num Events
      1
    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
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      52
      num Events
      1
    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
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      4
      num Events
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      3
      num Events
      1
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
      num Events
      1
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      6
      num Events
      1
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      6
      num Events
      1
    12. group Id
      EG011
      num Affected
      10
      num At Risk
      52
      num Events
      12
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      52
      num Events
      3
    term
    Abdominal pain lower
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
      num Events
      1
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      3
      num Events
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      52
      num Events
      4
    term
    Abdominal pain upper
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      4
      num Events
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      5
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      4
      num At Risk
      52
      num Events
      4
    term
    Alanine aminotransferase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Amnesia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      5
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
      num Events
      2
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      6
      num Events
      2
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      6
      num Events
      1
    12. group Id
      EG011
      num Affected
      5
      num At Risk
      52
      num Events
      6
    term
    Amylase increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      5
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      6
      num Events
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      5
      num At Risk
      52
      num Events
      5
    term
    Anaemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Angular cheilitis
  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
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Animal bite
  12. 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
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Animal scratch
Complete source fields
description
Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported.
event Groups
  1. deaths Num Affected
    3
    deaths Num At Risk
    4
    description
    Participants with advanced or metastatic select solid tumors received INCAGN01949 70 milligrams (mg) every 2 weeks (Q2W) beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as intravenous (IV) infusions.
    id
    EG000
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    3
    serious Num At Risk
    4
    title
    Phase 1, Dose Escalation: INCAGN01949 70 mg + Nivolumab 240 mg
  2. deaths Num Affected
    2
    deaths Num At Risk
    4
    description
    Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.
    id
    EG001
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    1
    serious Num At Risk
    4
    title
    Phase 1, Dose Escalation: INCAGN01949 200 mg + Nivolumab 240 mg
  3. deaths Num Affected
    4
    deaths Num At Risk
    5
    description
    Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.
    id
    EG002
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    4
    serious Num At Risk
    5
    title
    Phase 1, Dose Escalation: INCAGN01949 350 mg + Nivolumab 240 mg
  4. deaths Num Affected
    4
    deaths Num At Risk
    5
    description
    Participants with advanced or metastatic select solid tumors received INCAGN01949 700 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.
    id
    EG003
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    3
    serious Num At Risk
    5
    title
    Phase 1, Dose Escalation: INCAGN01949 700 mg + Nivolumab 240 mg
  5. deaths Num Affected
    2
    deaths Num At Risk
    4
    description
    Participants with advanced or metastatic select solid tumors received INCAGN01949 70 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kilogram (kg) every 6 weeks (Q6W) beginning on Cycle 1 Day 1, administered as IV infusions.
    id
    EG004
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    2
    serious Num At Risk
    4
    title
    Phase 1, Dose Escalation: INCAGN01949 70 mg + Ipilimumab 1 mg/kg
  6. deaths Num Affected
    2
    deaths Num At Risk
    5
    description
    Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.
    id
    EG005
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    2
    serious Num At Risk
    5
    title
    Phase 1, Dose Escalation: INCAGN01949 200 mg + Ipilimumab 1 mg/kg
  7. deaths Num Affected
    3
    deaths Num At Risk
    4
    description
    Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.
    id
    EG006
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    2
    serious Num At Risk
    4
    title
    Phase 1, Dose Escalation: INCAGN01949 350 mg + Ipilimumab 1 mg/kg
  8. deaths Num Affected
    1
    deaths Num At Risk
    3
    description
    Participants with advanced or metastatic select solid tumors received INCAGN01949 700 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.
    id
    EG007
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    Phase 1, Dose Escalation: INCAGN01949 700 mg + Ipilimumab 1 mg/kg
  9. deaths Num Affected
    5
    deaths Num At Risk
    6
    description
    Participants with advanced or metastatic select solid tumors received INCAGN01949 70 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.
    id
    EG008
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    4
    serious Num At Risk
    6
    title
    Phase 1, Safety Expansion: INCAGN01949 70 mg + Nivolumab 240 mg
  10. deaths Num Affected
    4
    deaths Num At Risk
    6
    description
    Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.
    id
    EG009
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    3
    serious Num At Risk
    6
    title
    Phase 1, Safety Expansion: INCAGN01949 200 mg + Nivolumab 240 mg
  11. deaths Num Affected
    3
    deaths Num At Risk
    6
    description
    Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.
    id
    EG010
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    3
    serious Num At Risk
    6
    title
    Phase 1, Safety Expansion: INCAGN01949 350 mg + Nivolumab 240 mg
  12. deaths Num Affected
    33
    deaths Num At Risk
    52
    description
    Total
    id
    EG011
    other Num Affected
    52
    other Num At Risk
    52
    serious Num Affected
    28
    serious Num At Risk
    52
    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
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      52
      num Events
      1
    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
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      52
      num Events
      1
    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
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      4
      num Events
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      3
      num Events
      1
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
      num Events
      1
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      6
      num Events
      1
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      6
      num Events
      1
    12. group Id
      EG011
      num Affected
      10
      num At Risk
      52
      num Events
      12
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      52
      num Events
      3
    term
    Abdominal pain lower
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
      num Events
      1
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      3
      num Events
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      52
      num Events
      4
    term
    Abdominal pain upper
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      4
      num Events
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      5
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      4
      num At Risk
      52
      num Events
      4
    term
    Alanine aminotransferase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Amnesia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      5
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
      num Events
      2
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      6
      num Events
      2
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      6
      num Events
      1
    12. group Id
      EG011
      num Affected
      5
      num At Risk
      52
      num Events
      6
    term
    Amylase increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      5
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      6
      num Events
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      5
      num At Risk
      52
      num Events
      5
    term
    Anaemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Angular cheilitis
  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
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Animal bite
  12. 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
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Animal scratch
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Adrenal insufficiency
  2. 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
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      6
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      5
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Cholangitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      6
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Cholestasis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Coronary artery disease
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      6
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Death
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Dehydration
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      5
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Dermatitis contact
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      5
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Dysphagia
  11. 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
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
      num Events
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      52
      num Events
      3
    term
    Dyspnoea
  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
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Failure to thrive
time Frame
up to 17.4 months

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Preserved source evidence · Not medical advice