Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03126110 · ADVERSE EVENTS

Adverse events

Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 Combined With Immune Therapies in Advanced or Metastatic Malignancies · Source last updated 2025-08-14

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

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

Collection time frame
up to approximately 27.4 months
Other-event reporting threshold
5%

Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W

Participants received INCAGN01876 1.0 milligrams per kilogram (mg/kg) administered intravenously (IV) every 2 weeks (Q2W) in combination with nivolumab 240 mg administered IV Q2W.

2 / 44 / 42 / 4
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W

Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

2 / 44 / 42 / 4
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W

Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

3 / 55 / 54 / 5
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W

Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

2 / 43 / 43 / 4
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W

Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.

2 / 55 / 54 / 5
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W

Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.

1 / 44 / 44 / 4
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W

Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.

2 / 44 / 43 / 4
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W

Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV every 6 weeks (Q6W).

2 / 44 / 44 / 4
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W

Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.

3 / 87 / 85 / 8
Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W

Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.

1 / 33 / 32 / 3
Phase 1 Group D: INCAGN01876 + Nivolumab + Ipilimumab

Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.

2 / 66 / 66 / 6
Phase 2 Group C2 PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kg

Participants with programmed cell death protein/programmed cell death ligand 1 (PD-1/PD-L1) relapsed melanoma (RM) received INCAGN01876 300 mg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.

3 / 88 / 86 / 8
Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg

Participants with gastric cancer (GC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

11 / 1615 / 1612 / 16
Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg

Participants with squamous cell carcinoma of the head and neck (SCCHN) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

19 / 4643 / 4625 / 46
Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg

Participants with cervical cancer (CC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

10 / 1818 / 1811 / 18
Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg

Participants with PD-1/PD-L1 relapsed melanoma received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

2 / 44 / 43 / 4
Phase 2 Group F Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg

Participants with gastric cancer, squamous cell carcinoma of the head and neck, cervical cancer, or PD-1/PD-L1 relapsed melanoma who had tumor lesions that were amenable to percutaneous biopsy received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.

1 / 22 / 22 / 2
Total

Total

68 / 145139 / 14598 / 145

Group identifiers: EG000: Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W · EG001: Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W · EG002: Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W · EG003: Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W · EG004: Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W · EG005: Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W · EG006: Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W · EG007: Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W · EG008: Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W · EG009: Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W · EG010: Phase 1 Group D: INCAGN01876 + Nivolumab + Ipilimumab · EG011: Phase 2 Group C2 PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kg · EG012: Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg · EG013: Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg · EG014: Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg · EG015: Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg · EG016: Phase 2 Group F Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg · EG017: 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 24
    stats
    1. group Id
      EG000
      num Affected
      1
      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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      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
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24
    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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      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
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Abdominal pain upper
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24
    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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      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
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Acute myocardial infarction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 24
    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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      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
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Acute respiratory failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24
    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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      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
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      3
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Anaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24
    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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      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
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Appendicitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 24
    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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      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
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Arthritis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24
    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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
      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
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Ascites
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24
    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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      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
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Atrial fibrillation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24
    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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      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
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Atrioventricular block
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24
    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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      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
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      8
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Bacteraemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 24
    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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      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
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      6
      num Events
      1
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Breast cancer metastatic

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 24
    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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      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
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      8
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      6
      num Events
      1
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Abdominal discomfort
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24
    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
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      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
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      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
      8
      num Events
      1
    term
    Abdominal distension
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24
    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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      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
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      8
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      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
      8
      num Events
      1
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24
    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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      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
      4
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Abdominal pain lower
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24
    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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      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
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      8
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Abdominal pain upper
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 24
    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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      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
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      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
      8
      num Events
      1
    term
    Acute kidney injury
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 24
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      2
    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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      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
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      6
      num Events
      1
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Alanine aminotransferase increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 24
    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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      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
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Allodynia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 24
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      3
    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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      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
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      8
      num Events
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Amylase increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      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
      4
      num Events
      1
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      8
      num Events
      1
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      3
      num Events
      1
    11. group Id
      EG010
      num Affected
      3
      num At Risk
      6
      num Events
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Anaemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24
    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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      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
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Anorectal discomfort
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 24
    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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
      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
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Anxiety
Complete source fields
description
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
event Groups
  1. deaths Num Affected
    2
    deaths Num At Risk
    4
    description
    Participants received INCAGN01876 1.0 milligrams per kilogram (mg/kg) administered intravenously (IV) every 2 weeks (Q2W) in combination with nivolumab 240 mg administered IV Q2W.
    id
    EG000
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    2
    serious Num At Risk
    4
    title
    Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W
  2. deaths Num Affected
    2
    deaths Num At Risk
    4
    description
    Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
    id
    EG001
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    2
    serious Num At Risk
    4
    title
    Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W
  3. deaths Num Affected
    4
    deaths Num At Risk
    5
    description
    Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
    id
    EG002
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    3
    serious Num At Risk
    5
    title
    Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W
  4. deaths Num Affected
    3
    deaths Num At Risk
    4
    description
    Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
    id
    EG003
    other Num Affected
    3
    other Num At Risk
    4
    serious Num Affected
    2
    serious Num At Risk
    4
    title
    Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W
  5. deaths Num Affected
    4
    deaths Num At Risk
    5
    description
    Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
    id
    EG004
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    2
    serious Num At Risk
    5
    title
    Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
  6. deaths Num Affected
    4
    deaths Num At Risk
    4
    description
    Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
    id
    EG005
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    1
    serious Num At Risk
    4
    title
    Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
  7. deaths Num Affected
    3
    deaths Num At Risk
    4
    description
    Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
    id
    EG006
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    2
    serious Num At Risk
    4
    title
    Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
  8. deaths Num Affected
    4
    deaths Num At Risk
    4
    description
    Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV every 6 weeks (Q6W).
    id
    EG007
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    2
    serious Num At Risk
    4
    title
    Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
  9. deaths Num Affected
    5
    deaths Num At Risk
    8
    description
    Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
    id
    EG008
    other Num Affected
    7
    other Num At Risk
    8
    serious Num Affected
    3
    serious Num At Risk
    8
    title
    Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
  10. deaths Num Affected
    2
    deaths Num At Risk
    3
    description
    Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
    id
    EG009
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
  11. deaths Num Affected
    6
    deaths Num At Risk
    6
    description
    Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
    id
    EG010
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    2
    serious Num At Risk
    6
    title
    Phase 1 Group D: INCAGN01876 + Nivolumab + Ipilimumab
  12. deaths Num Affected
    6
    deaths Num At Risk
    8
    description
    Participants with programmed cell death protein/programmed cell death ligand 1 (PD-1/PD-L1) relapsed melanoma (RM) received INCAGN01876 300 mg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
    id
    EG011
    other Num Affected
    8
    other Num At Risk
    8
    serious Num Affected
    3
    serious Num At Risk
    8
    title
    Phase 2 Group C2 PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kg
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24
    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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      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
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      8
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      6
      num Events
      1
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Abdominal discomfort
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24
    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
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      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
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      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
      8
      num Events
      1
    term
    Abdominal distension
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24
    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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      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
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      8
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      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
      8
      num Events
      1
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24
    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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      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
      4
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Abdominal pain lower
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24
    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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      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
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      8
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Abdominal pain upper
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 24
    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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      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
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      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
      8
      num Events
      1
    term
    Acute kidney injury
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 24
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      2
    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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      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
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      6
      num Events
      1
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Alanine aminotransferase increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 24
    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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      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
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Allodynia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 24
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      3
    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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      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
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      8
      num Events
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Amylase increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      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
      4
      num Events
      1
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      8
      num Events
      1
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      3
      num Events
      1
    11. group Id
      EG010
      num Affected
      3
      num At Risk
      6
      num Events
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Anaemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24
    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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      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
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Anorectal discomfort
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 24
    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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
      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
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Anxiety
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24
    stats
    1. group Id
      EG000
      num Affected
      1
      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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      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
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24
    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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      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
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Abdominal pain upper
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24
    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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      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
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Acute myocardial infarction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 24
    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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      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
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Acute respiratory failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24
    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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      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
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      3
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Anaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24
    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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      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
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Appendicitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 24
    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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      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
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Arthritis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24
    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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
      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
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Ascites
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24
    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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      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
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Atrial fibrillation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24
    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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      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
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Atrioventricular block
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24
    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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      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
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      8
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      6
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Bacteraemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 24
    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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      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
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      6
      num Events
      1
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Breast cancer metastatic
time Frame
up to approximately 27.4 months

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

Preserved source evidence · Not medical advice