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NCT03717415 · ADVERSE EVENTS

Adverse events

A Study of Rebastinib (DCC-2036) in Combination With Carboplatin in Patients With Advanced or Metastatic Solid Tumors · Source last updated 2024-12-27

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
Baseline up to 2.32 years
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Part 1 Cohort 1 Escalation Rebastinib 50 mg + Carboplatin AUC5

Dose escalation with rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.

2 / 33 / 30 / 3
Part 1 Cohort 2 Escalation Rebastinib 100 mg + Carboplatin AUC5

Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.

4 / 1413 / 140 / 14
Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC6

Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC6 at Day 1 of each 21-day cycle.

1 / 55 / 51 / 5
Part 2 Cohort 1 Expansion Rebastinib 50 mg + Carboplatin AUC5

Dose expansion in TNBC participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.

5 / 99 / 90 / 9
Part 2 Cohort 1 Expansion Rebastinib 100 mg + Carboplatin AUC5

Dose expansion in TNBC participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.

0 / 22 / 20 / 2
Part 2 Cohort 2 Expansion Rebastinib 50 mg + Carboplatin AUC5

Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.

6 / 1818 / 180 / 18
Part 2 Cohort 2 Expansion Rebastinib 100 mg + Carboplatin AUC5

Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.

0 / 22 / 20 / 2
Part 2 Cohort 3 Expansion Rebastinib 50 mg + Carboplatin AUC5

Dose expansion in mesothelioma participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.

2 / 66 / 60 / 6
Part 2 Cohort 3 Expansion Rebastinib 100 mg + Carboplatin AUC5

Dose expansion in mesothelioma participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.

6 / 1111 / 113 / 11

Group identifiers: EG000: Part 1 Cohort 1 Escalation Rebastinib 50 mg + Carboplatin AUC5 · EG001: Part 1 Cohort 2 Escalation Rebastinib 100 mg + Carboplatin AUC5 · EG002: Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC6 · EG003: Part 2 Cohort 1 Expansion Rebastinib 50 mg + Carboplatin AUC5 · EG004: Part 2 Cohort 1 Expansion Rebastinib 100 mg + Carboplatin AUC5 · EG005: Part 2 Cohort 2 Expansion Rebastinib 50 mg + Carboplatin AUC5 · EG006: Part 2 Cohort 2 Expansion Rebastinib 100 mg + Carboplatin AUC5 · EG007: Part 2 Cohort 3 Expansion Rebastinib 50 mg + Carboplatin AUC5 · EG008: Part 2 Cohort 3 Expansion Rebastinib 100 mg + Carboplatin AUC5

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
    Cardiac disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
      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
      9
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      18
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Cardiac failure
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      18
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Coronary artery disease
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      18
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Myocardial infarction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
      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
      9
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      18
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Pericardial effusion
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      18
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Retinal vascular disorder
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      18
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Retinal vein occlusion
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      18
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      18
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Gastric stenosis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
      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
      9
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      18
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      18
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Oesophagitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      18
      num Events
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      6
      num Events
      2
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      11
      num Events
      2
    term
    Small intestinal obstruction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      18
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Asthenia

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      14
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      18
      num Events
      5
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      2
      num Events
      1
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
      num Events
      1
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      11
      num Events
      5
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      14
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      18
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
      num Events
      1
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      11
      num Events
      2
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      18
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      6
      num Events
      2
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      14
      num Events
      9
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      5
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      18
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
      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
      9
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      18
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      18
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Conduction disorder
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      18
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Extrasystoles
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
      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
      9
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      18
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Pericardial effusion
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      18
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Sinus bradycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      18
      num Events
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Sinus tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      18
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      2
      num Events
      1
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      6
      num Events
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Tachycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      18
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Corneal dystrophy
Complete source fields
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Dose escalation with rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
    id
    EG000
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    2
    serious Num At Risk
    3
    title
    Part 1 Cohort 1 Escalation Rebastinib 50 mg + Carboplatin AUC5
  2. deaths Num Affected
    0
    deaths Num At Risk
    14
    description
    Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
    id
    EG001
    other Num Affected
    13
    other Num At Risk
    14
    serious Num Affected
    4
    serious Num At Risk
    14
    title
    Part 1 Cohort 2 Escalation Rebastinib 100 mg + Carboplatin AUC5
  3. deaths Num Affected
    1
    deaths Num At Risk
    5
    description
    Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC6 at Day 1 of each 21-day cycle.
    id
    EG002
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    1
    serious Num At Risk
    5
    title
    Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC6
  4. deaths Num Affected
    0
    deaths Num At Risk
    9
    description
    Dose expansion in TNBC participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
    id
    EG003
    other Num Affected
    9
    other Num At Risk
    9
    serious Num Affected
    5
    serious Num At Risk
    9
    title
    Part 2 Cohort 1 Expansion Rebastinib 50 mg + Carboplatin AUC5
  5. deaths Num Affected
    0
    deaths Num At Risk
    2
    description
    Dose expansion in TNBC participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
    id
    EG004
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    0
    serious Num At Risk
    2
    title
    Part 2 Cohort 1 Expansion Rebastinib 100 mg + Carboplatin AUC5
  6. deaths Num Affected
    0
    deaths Num At Risk
    18
    description
    Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
    id
    EG005
    other Num Affected
    18
    other Num At Risk
    18
    serious Num Affected
    6
    serious Num At Risk
    18
    title
    Part 2 Cohort 2 Expansion Rebastinib 50 mg + Carboplatin AUC5
  7. deaths Num Affected
    0
    deaths Num At Risk
    2
    description
    Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
    id
    EG006
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    0
    serious Num At Risk
    2
    title
    Part 2 Cohort 2 Expansion Rebastinib 100 mg + Carboplatin AUC5
  8. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    Dose expansion in mesothelioma participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
    id
    EG007
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    2
    serious Num At Risk
    6
    title
    Part 2 Cohort 3 Expansion Rebastinib 50 mg + Carboplatin AUC5
  9. deaths Num Affected
    3
    deaths Num At Risk
    11
    description
    Dose expansion in mesothelioma participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
    id
    EG008
    other Num Affected
    11
    other Num At Risk
    11
    serious Num Affected
    6
    serious Num At Risk
    11
    title
    Part 2 Cohort 3 Expansion Rebastinib 100 mg + Carboplatin AUC5
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      14
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      18
      num Events
      5
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      2
      num Events
      1
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
      num Events
      1
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      11
      num Events
      5
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      14
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      18
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
      num Events
      1
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      11
      num Events
      2
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      18
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      6
      num Events
      2
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      14
      num Events
      9
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      5
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      18
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
      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
      9
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      18
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      18
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Conduction disorder
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      18
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Extrasystoles
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
      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
      9
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      18
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Pericardial effusion
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      18
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Sinus bradycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      18
      num Events
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Sinus tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      18
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      2
      num Events
      1
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      6
      num Events
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Tachycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      18
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Corneal dystrophy
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
      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
      9
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      18
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Cardiac failure
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      18
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Coronary artery disease
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      18
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Myocardial infarction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
      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
      9
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      18
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Pericardial effusion
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      18
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Retinal vascular disorder
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      18
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Retinal vein occlusion
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      18
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      18
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Gastric stenosis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
      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
      9
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      18
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      18
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Oesophagitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      18
      num Events
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      6
      num Events
      2
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      11
      num Events
      2
    term
    Small intestinal obstruction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
      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
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      18
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Asthenia
time Frame
Baseline up to 2.32 years

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Preserved source evidence · Not medical advice