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NCT02711137 · ADVERSE EVENTS

Adverse events

Open-Label Safety and Tolerability Study of INCB057643 in Subjects With Advanced Malignancies · Source last updated 2025-10-21

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
From screening through at least 30 days after end of treatment, up to approximately 24 months
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Part1/Treatment Group A : 8mg QD INCB057643

Part1/Treatment Group A : 8mg QD INCB057643 Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the TGA. Treatment Group A included solid tumors and lymphoma

2 / 44 / 42 / 4
Part1/Treatment Group A : 12mg QD INCB057643

Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the TGA. Treatment Group A included solid tumors and lymphoma

1 / 55 / 54 / 5
Part1/Treatment Group A : 16mg QD INCB057643

Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the TGA. Treatment Group A included solid tumors and lymphoma

4 / 87 / 85 / 8
Part1/Treatment Group B : 8mg QD INCB057643

Initial cohort dose of INCB054763 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included any acute leukemia, HRMDS, MDS/MPN, or MF.

5 / 77 / 76 / 7
Part1/Treatment Group B : 12mg QD INCB057643

Initial cohort dose of INCB054763 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included any acute leukemia, HRMDS, MDS/MPN, or MF.

4 / 55 / 54 / 5
Part1/Treatment Group C : 8mg QD INCB057643

Initial cohort dose of INCB054763 monotherapy at the protocol-specified cohort escalation treatment group C (TGC), based on protocol-specific criteria. Treatment Group C includes subjects with MM

1 / 10 / 11 / 1
Part2/Treatment Group A : 12 mg INCB057643 Expansion Cohort

Initial cohort dose of INCB054763 monotherapy at the specified RP2D dose selected in Part 1 cohort escalation treatment group A (TGA), based on protocol-specific criteria. Part 2 Treatment Group A expansion included pancreatic adenocarcinoma, castration-resistant prostrate cancer, breast cancer, high grade serious ovarian cancer, glioblastoma multiform, non-hodgkin's lymphoma, ewing's sarcoma, and solid tumor or lymphoma.

32 / 8682 / 8668 / 86
Part2/Treatment Group B : 12 mg INCB057643 Expansion Cohort

Initial cohort dose of INCB057463 monotherapy at the specified RP2D dose selected in Part 1 cohort escalation treatment group B (TGB), based on protocol-specific criteria. Part 2 Treatment Group B expansion included pancreatic adenocarcinoma, castration-resistant prostrate cancer, breast cancer, high grade serious ovarian cancer, glioblastoma multiform, non-hodgkin's lymphoma, ewing's sarcoma, and solid tumor or lymphoma.

4 / 55 / 53 / 5
Part3/Treatment Group A : 8 mg INCB057643 + Gemcitabine 1000mg

Initial cohort dose of INCB057643 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Gemcitabine) in relapsed or refractory advanced or metastatic solid tumors and hematologic malignancies where Gemcitabine is relevant

0 / 11 / 10 / 1
Part3/Treatment Group B : 8 mg INCB057643 + Paclitaxel 80mg

Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Paclitaxel) in relapsed or refractory advanced or metastatic solid tumors and hematologic malignancies.

0 / 22 / 21 / 2
Part3/Treatment Group C : 8 mg INCB057643 + Rucaparib 600mg

Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Rucaparib) in relapsed or refractory advanced or metastatic solid tumors and hematologic malignancies.

0 / 44 / 41 / 4
Part3/Treatment Group D : 8 mg INCB057643 + Abir +Predni

Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Abiraterone + Prednisone) in Castration Resistant Prostrate Cancer

1 / 33 / 31 / 3
Part3/Treatment Group E : 8 mg INCB057643 + Ruxolitinib 20mg

Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Ruxolitinib) in Myelofibrosis.

1 / 11 / 10 / 1
Part3/Treatment Group F : 8 mg INCB057643 + Azacitidine 75mg

Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Azacitidine) in Acute Myeloid Leukemia and Myelodysplastic Syndrome

0 / 22 / 20 / 2

Group identifiers: EG000: Part1/Treatment Group A : 8mg QD INCB057643 · EG001: Part1/Treatment Group A : 12mg QD INCB057643 · EG002: Part1/Treatment Group A : 16mg QD INCB057643 · EG003: Part1/Treatment Group B : 8mg QD INCB057643 · EG004: Part1/Treatment Group B : 12mg QD INCB057643 · EG005: Part1/Treatment Group C : 8mg QD INCB057643 · EG006: Part2/Treatment Group A : 12 mg INCB057643 Expansion Cohort · EG007: Part2/Treatment Group B : 12 mg INCB057643 Expansion Cohort · EG008: Part3/Treatment Group A : 8 mg INCB057643 + Gemcitabine 1000mg · EG009: Part3/Treatment Group B : 8 mg INCB057643 + Paclitaxel 80mg · EG010: Part3/Treatment Group C : 8 mg INCB057643 + Rucaparib 600mg · EG011: Part3/Treatment Group D : 8 mg INCB057643 + Abir +Predni · EG012: Part3/Treatment Group E : 8 mg INCB057643 + Ruxolitinib 20mg · EG013: Part3/Treatment Group F : 8 mg INCB057643 + Azacitidine 75mg

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 19
    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
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      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
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      86
      num Events
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19
    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
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      8
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      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
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      86
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Abdominal pain upper
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 19
    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
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      7
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      86
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      3
      num Events
      1
    term
    Acute kidney injury
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19
    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
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      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
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      86
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Acute myocardial infarction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 19
    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
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      86
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Acute respiratory distress syndrome
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 19
    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
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      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
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      86
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Acute respiratory failure
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19
    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
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      86
      num Events
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Anaemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 19
    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
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      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
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      86
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Appendicitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 19
    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
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      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
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      86
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Asthenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19
    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
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      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
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      86
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Atrial fibrillation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 19
    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
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      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
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      86
      num Events
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Back pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 19
    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
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      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
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      86
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Balance disorder

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 19
    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
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      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
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      86
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Abdominal distension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      5
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      8
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      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
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      86
      num Events
      3
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      5
      num Events
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
      num Events
      0
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
      num Events
      1
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19
    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
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      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
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      86
      num Events
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Abdominal pain upper
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 19
    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
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      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
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      86
      num Events
      1
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      5
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Acne
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 19
    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
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      86
      num Events
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Activated partial thromboplastin time prolonged
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 19
    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
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      8
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      7
      num At Risk
      86
      num Events
      8
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      5
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Acute kidney injury
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 19
    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
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      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
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      86
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
      num Events
      0
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
      num Events
      1
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Acute sinusitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 19
    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
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      86
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Agitation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 19
    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
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      8
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      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
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      7
      num At Risk
      86
      num Events
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Alanine aminotransferase increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 19
    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
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      86
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      2
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Alopecia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19
    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
      5
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      8
      num Events
      3
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      7
      num Events
      4
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      5
      num Events
      9
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      15
      num At Risk
      86
      num Events
      17
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      5
      num Events
      11
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      2
      num Events
      3
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      4
      num Events
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Anaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19
    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
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      86
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Anal fissure
Complete source fields
event Groups
  1. deaths Num Affected
    2
    deaths Num At Risk
    4
    description
    Part1/Treatment Group A : 8mg QD INCB057643 Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the TGA. Treatment Group A included solid tumors and lymphoma
    id
    EG000
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    2
    serious Num At Risk
    4
    title
    Part1/Treatment Group A : 8mg QD INCB057643
  2. deaths Num Affected
    4
    deaths Num At Risk
    5
    description
    Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the TGA. Treatment Group A included solid tumors and lymphoma
    id
    EG001
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    1
    serious Num At Risk
    5
    title
    Part1/Treatment Group A : 12mg QD INCB057643
  3. deaths Num Affected
    5
    deaths Num At Risk
    8
    description
    Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the TGA. Treatment Group A included solid tumors and lymphoma
    id
    EG002
    other Num Affected
    7
    other Num At Risk
    8
    serious Num Affected
    4
    serious Num At Risk
    8
    title
    Part1/Treatment Group A : 16mg QD INCB057643
  4. deaths Num Affected
    6
    deaths Num At Risk
    7
    description
    Initial cohort dose of INCB054763 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included any acute leukemia, HRMDS, MDS/MPN, or MF.
    id
    EG003
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    5
    serious Num At Risk
    7
    title
    Part1/Treatment Group B : 8mg QD INCB057643
  5. deaths Num Affected
    4
    deaths Num At Risk
    5
    description
    Initial cohort dose of INCB054763 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included any acute leukemia, HRMDS, MDS/MPN, or MF.
    id
    EG004
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    4
    serious Num At Risk
    5
    title
    Part1/Treatment Group B : 12mg QD INCB057643
  6. deaths Num Affected
    1
    deaths Num At Risk
    1
    description
    Initial cohort dose of INCB054763 monotherapy at the protocol-specified cohort escalation treatment group C (TGC), based on protocol-specific criteria. Treatment Group C includes subjects with MM
    id
    EG005
    other Num Affected
    0
    other Num At Risk
    1
    serious Num Affected
    1
    serious Num At Risk
    1
    title
    Part1/Treatment Group C : 8mg QD INCB057643
  7. deaths Num Affected
    68
    deaths Num At Risk
    86
    description
    Initial cohort dose of INCB054763 monotherapy at the specified RP2D dose selected in Part 1 cohort escalation treatment group A (TGA), based on protocol-specific criteria. Part 2 Treatment Group A expansion included pancreatic adenocarcinoma, castration-resistant prostrate cancer, breast cancer, high grade serious ovarian cancer, glioblastoma multiform, non-hodgkin's lymphoma, ewing's sarcoma, and solid tumor or lymphoma.
    id
    EG006
    other Num Affected
    82
    other Num At Risk
    86
    serious Num Affected
    32
    serious Num At Risk
    86
    title
    Part2/Treatment Group A : 12 mg INCB057643 Expansion Cohort
  8. deaths Num Affected
    3
    deaths Num At Risk
    5
    description
    Initial cohort dose of INCB057463 monotherapy at the specified RP2D dose selected in Part 1 cohort escalation treatment group B (TGB), based on protocol-specific criteria. Part 2 Treatment Group B expansion included pancreatic adenocarcinoma, castration-resistant prostrate cancer, breast cancer, high grade serious ovarian cancer, glioblastoma multiform, non-hodgkin's lymphoma, ewing's sarcoma, and solid tumor or lymphoma.
    id
    EG007
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    4
    serious Num At Risk
    5
    title
    Part2/Treatment Group B : 12 mg INCB057643 Expansion Cohort
  9. deaths Num Affected
    0
    deaths Num At Risk
    1
    description
    Initial cohort dose of INCB057643 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Gemcitabine) in relapsed or refractory advanced or metastatic solid tumors and hematologic malignancies where Gemcitabine is relevant
    id
    EG008
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    0
    serious Num At Risk
    1
    title
    Part3/Treatment Group A : 8 mg INCB057643 + Gemcitabine 1000mg
  10. deaths Num Affected
    1
    deaths Num At Risk
    2
    description
    Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Paclitaxel) in relapsed or refractory advanced or metastatic solid tumors and hematologic malignancies.
    id
    EG009
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    0
    serious Num At Risk
    2
    title
    Part3/Treatment Group B : 8 mg INCB057643 + Paclitaxel 80mg
  11. deaths Num Affected
    1
    deaths Num At Risk
    4
    description
    Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Rucaparib) in relapsed or refractory advanced or metastatic solid tumors and hematologic malignancies.
    id
    EG010
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    0
    serious Num At Risk
    4
    title
    Part3/Treatment Group C : 8 mg INCB057643 + Rucaparib 600mg
  12. deaths Num Affected
    1
    deaths Num At Risk
    3
    description
    Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Abiraterone + Prednisone) in Castration Resistant Prostrate Cancer
    id
    EG011
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    Part3/Treatment Group D : 8 mg INCB057643 + Abir +Predni
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19
    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
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      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
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      86
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Abdominal distension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      5
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      8
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      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
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      86
      num Events
      3
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      5
      num Events
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
      num Events
      0
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
      num Events
      1
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19
    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
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      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
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      86
      num Events
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Abdominal pain upper
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 19
    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
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      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
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      86
      num Events
      1
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      5
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Acne
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 19
    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
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      86
      num Events
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Activated partial thromboplastin time prolonged
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 19
    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
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      8
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      7
      num At Risk
      86
      num Events
      8
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      5
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Acute kidney injury
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 19
    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
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      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
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      86
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
      num Events
      0
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
      num Events
      1
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Acute sinusitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 19
    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
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      86
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Agitation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 19
    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
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      8
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      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
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      7
      num At Risk
      86
      num Events
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Alanine aminotransferase increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 19
    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
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      86
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      2
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Alopecia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19
    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
      5
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      8
      num Events
      3
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      7
      num Events
      4
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      5
      num Events
      9
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      15
      num At Risk
      86
      num Events
      17
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      5
      num Events
      11
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      2
      num Events
      3
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      4
      num Events
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Anaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19
    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
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      86
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Anal fissure
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19
    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
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      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
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      86
      num Events
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19
    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
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      8
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      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
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      86
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Abdominal pain upper
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 19
    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
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      7
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      86
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      3
      num Events
      1
    term
    Acute kidney injury
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19
    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
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      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
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      86
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Acute myocardial infarction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 19
    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
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      86
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Acute respiratory distress syndrome
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 19
    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
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      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
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      86
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Acute respiratory failure
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19
    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
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      86
      num Events
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Anaemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 19
    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
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      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
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      86
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Appendicitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 19
    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
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      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
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      86
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Asthenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19
    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
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      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
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      86
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Atrial fibrillation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 19
    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
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      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
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      86
      num Events
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Back pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 19
    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
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      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
      1
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      86
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      2
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Balance disorder
time Frame
From screening through at least 30 days after end of treatment, up to approximately 24 months

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Preserved source evidence · Not medical advice