Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02264613 · ADVERSE EVENTS

Adverse events

ALRN-6924 in Patients With Advanced Solid Tumors or Lymphomas · Source last updated 2026-01-13

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 Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Dose Regimen A (DR-A) Escalation (0.16 mg/kg)

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion

0 / 55 / 50 / 5
Dose Regimen A (DR-A) Escalation (0.32 mg/kg)

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion

0 / 33 / 30 / 3
Dose Regimen A (DR-A) Escalation (0.64 mg/kg)

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion

0 / 44 / 40 / 4
Dose Regimen A (DR-A) Escalation (1.25 mg/kg)

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion

1 / 33 / 30 / 3
Dose Regimen A (DR-A) Escalation (2.1 mg/kg)

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion

0 / 66 / 60 / 6
Dose Regimen A (DR-A) Escalation (3.1 mg/kg)

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion

2 / 99 / 90 / 9
Dose Regimen A (DR-A) Escalation (4.4 mg/kg)

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion

4 / 1111 / 110 / 11
Dose Regimen B (DR-B) Escalation (0.32 mg/kg)

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion

0 / 33 / 30 / 3
Dose Regimen B (DR-B) Escalation (0.53 mg/kg)

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion

1 / 55 / 50 / 5
Dose Regimen B (DR-B) Escalation (0.8 mg/kg)

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion

0 / 33 / 30 / 3
Dose Regimen B (DR-B) Escalation (1.1 mg/kg)

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion

0 / 44 / 40 / 4
Dose Regimen B (DR-B) Escalation (1.5 mg/kg)

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion

0 / 44 / 40 / 4
Dose Regimen B (DR-B) Escalation (2.0 mg/kg)

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion

0 / 55 / 50 / 5
Dose Regimen B (DR-B) Escalation (2.7 mg/kg)

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion

0 / 66 / 60 / 6
Dose Regimen A (DR-A) PTCL Expansion

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion

7 / 2119 / 210 / 21
Dose Regimen C (DR-C) PTCL Expansion

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 3 and 5 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion

7 / 1615 / 160 / 16
Combination With Palbociclib Expansion

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle Drug: Palbociclib Fixed-dose capsule administered orally on days 1 through 21 of a 28-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion

5 / 3434 / 345 / 34

Group identifiers: EG000: Dose Regimen A (DR-A) Escalation (0.16 mg/kg) · EG001: Dose Regimen A (DR-A) Escalation (0.32 mg/kg) · EG002: Dose Regimen A (DR-A) Escalation (0.64 mg/kg) · EG003: Dose Regimen A (DR-A) Escalation (1.25 mg/kg) · EG004: Dose Regimen A (DR-A) Escalation (2.1 mg/kg) · EG005: Dose Regimen A (DR-A) Escalation (3.1 mg/kg) · EG006: Dose Regimen A (DR-A) Escalation (4.4 mg/kg) · EG007: Dose Regimen B (DR-B) Escalation (0.32 mg/kg) · EG008: Dose Regimen B (DR-B) Escalation (0.53 mg/kg) · EG009: Dose Regimen B (DR-B) Escalation (0.8 mg/kg) · EG010: Dose Regimen B (DR-B) Escalation (1.1 mg/kg) · EG011: Dose Regimen B (DR-B) Escalation (1.5 mg/kg) · EG012: Dose Regimen B (DR-B) Escalation (2.0 mg/kg) · EG013: Dose Regimen B (DR-B) Escalation (2.7 mg/kg) · EG014: Dose Regimen A (DR-A) PTCL Expansion · EG015: Dose Regimen C (DR-C) PTCL Expansion · EG016: Combination With Palbociclib Expansion

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      9
      num Events
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    hypotension
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    thrombocytopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Nausea
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Vomitting
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Pulmonary Embolism
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      5
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    AKI
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      5
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    hypercalcemia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Subarachnoid Hemorrhage
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Subdural Hemorrhage
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Constipation
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Hyponatraemia

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      4
      num Events
      2
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      3
      num Events
      3
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      6
      num Events
      5
    6. group Id
      EG005
      num Affected
      9
      num At Risk
      9
      num Events
      9
    7. group Id
      EG006
      num Affected
      6
      num At Risk
      11
      num Events
      6
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      3
      num Events
      3
    9. group Id
      EG008
      num Affected
      4
      num At Risk
      5
      num Events
      4
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      3
      num Events
      3
    11. group Id
      EG010
      num Affected
      3
      num At Risk
      4
      num Events
      3
    12. group Id
      EG011
      num Affected
      4
      num At Risk
      4
      num Events
      4
    term
    Nausea
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      3
      num Events
      2
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      6
      num Events
      4
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      9
      num Events
      7
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      11
      num Events
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      3
      num Events
      1
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      5
      num Events
      2
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      3
      num Events
      3
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      4
      num Events
      2
    12. group Id
      EG011
      num Affected
      2
      num At Risk
      4
      num Events
      2
    term
    Vomitting
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
      num Events
      1
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      9
      num Events
      2
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      11
      num Events
      2
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      3
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      3
      num Events
      3
    11. group Id
      EG010
      num Affected
      3
      num At Risk
      4
      num Events
      3
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      4
      num Events
      1
    term
    Constipation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      3
      num Events
      2
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      6
      num Events
      3
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      9
      num Events
      2
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      3
      num Events
      1
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
      num Events
      1
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      4
      num Events
      1
    term
    Diarrhea
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
      num Events
      1
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      9
      num Events
      2
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      3
      num Events
      1
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      5
      num Events
      1
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      3
      num Events
      2
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
      num Events
      1
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      4
      num Events
      1
    term
    Abdominal Pain
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      5
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      4
      num Events
      2
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      3
      num Events
      3
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      6
      num Events
      5
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      9
      num Events
      4
    7. group Id
      EG006
      num Affected
      9
      num At Risk
      11
      num Events
      9
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      3
      num Events
      2
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      5
      num Events
      2
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      3
      num Events
      1
    11. group Id
      EG010
      num Affected
      3
      num At Risk
      4
      num Events
      3
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      4
      num Events
      3
    term
    Fatigue
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
      num Events
      1
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      11
      num Events
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Asthenia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
      num Events
      1
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      11
      num Events
      1
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      3
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      3
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Pyrexia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      4
      num Events
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      3
      num Events
      2
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      6
      num Events
      3
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      9
      num Events
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      11
      num Events
      1
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      3
      num Events
      2
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      5
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
      num Events
      1
    12. group Id
      EG011
      num Affected
      2
      num At Risk
      4
      num Events
      2
    term
    Decreased Appetite
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      5
      num Events
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Hyponatremia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      3
      num Events
      2
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      6
      num Events
      2
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      9
      num Events
      2
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      11
      num Events
      2
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      3
      num Events
      1
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      5
      num Events
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      4
      num Events
      2
    12. group Id
      EG011
      num Affected
      2
      num At Risk
      4
      num Events
      2
    term
    Headache
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      9
      num Events
      2
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      11
      num Events
      2
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      3
      num Events
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      4
      num Events
      1
    term
    Dizziness
Complete source fields
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    5
    description
    Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion
    id
    EG000
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    0
    serious Num At Risk
    5
    title
    Dose Regimen A (DR-A) Escalation (0.16 mg/kg)
  2. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion
    id
    EG001
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    Dose Regimen A (DR-A) Escalation (0.32 mg/kg)
  3. deaths Num Affected
    0
    deaths Num At Risk
    4
    description
    Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion
    id
    EG002
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    0
    serious Num At Risk
    4
    title
    Dose Regimen A (DR-A) Escalation (0.64 mg/kg)
  4. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion
    id
    EG003
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    Dose Regimen A (DR-A) Escalation (1.25 mg/kg)
  5. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion
    id
    EG004
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    0
    serious Num At Risk
    6
    title
    Dose Regimen A (DR-A) Escalation (2.1 mg/kg)
  6. deaths Num Affected
    0
    deaths Num At Risk
    9
    description
    Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion
    id
    EG005
    other Num Affected
    9
    other Num At Risk
    9
    serious Num Affected
    2
    serious Num At Risk
    9
    title
    Dose Regimen A (DR-A) Escalation (3.1 mg/kg)
  7. deaths Num Affected
    0
    deaths Num At Risk
    11
    description
    Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion
    id
    EG006
    other Num Affected
    11
    other Num At Risk
    11
    serious Num Affected
    4
    serious Num At Risk
    11
    title
    Dose Regimen A (DR-A) Escalation (4.4 mg/kg)
  8. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion
    id
    EG007
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    Dose Regimen B (DR-B) Escalation (0.32 mg/kg)
  9. deaths Num Affected
    0
    deaths Num At Risk
    5
    description
    Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion
    id
    EG008
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    1
    serious Num At Risk
    5
    title
    Dose Regimen B (DR-B) Escalation (0.53 mg/kg)
  10. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion
    id
    EG009
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    Dose Regimen B (DR-B) Escalation (0.8 mg/kg)
  11. deaths Num Affected
    0
    deaths Num At Risk
    4
    description
    Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion
    id
    EG010
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    0
    serious Num At Risk
    4
    title
    Dose Regimen B (DR-B) Escalation (1.1 mg/kg)
  12. deaths Num Affected
    0
    deaths Num At Risk
    4
    description
    Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion
    id
    EG011
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    0
    serious Num At Risk
    4
    title
    Dose Regimen B (DR-B) Escalation (1.5 mg/kg)
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      4
      num Events
      2
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      3
      num Events
      3
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      6
      num Events
      5
    6. group Id
      EG005
      num Affected
      9
      num At Risk
      9
      num Events
      9
    7. group Id
      EG006
      num Affected
      6
      num At Risk
      11
      num Events
      6
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      3
      num Events
      3
    9. group Id
      EG008
      num Affected
      4
      num At Risk
      5
      num Events
      4
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      3
      num Events
      3
    11. group Id
      EG010
      num Affected
      3
      num At Risk
      4
      num Events
      3
    12. group Id
      EG011
      num Affected
      4
      num At Risk
      4
      num Events
      4
    term
    Nausea
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      3
      num Events
      2
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      6
      num Events
      4
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      9
      num Events
      7
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      11
      num Events
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      3
      num Events
      1
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      5
      num Events
      2
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      3
      num Events
      3
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      4
      num Events
      2
    12. group Id
      EG011
      num Affected
      2
      num At Risk
      4
      num Events
      2
    term
    Vomitting
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
      num Events
      1
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      9
      num Events
      2
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      11
      num Events
      2
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      3
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      3
      num Events
      3
    11. group Id
      EG010
      num Affected
      3
      num At Risk
      4
      num Events
      3
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      4
      num Events
      1
    term
    Constipation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      3
      num Events
      2
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      6
      num Events
      3
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      9
      num Events
      2
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      3
      num Events
      1
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
      num Events
      1
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      4
      num Events
      1
    term
    Diarrhea
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
      num Events
      1
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      9
      num Events
      2
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      3
      num Events
      1
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      5
      num Events
      1
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      3
      num Events
      2
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
      num Events
      1
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      4
      num Events
      1
    term
    Abdominal Pain
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      5
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      4
      num Events
      2
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      3
      num Events
      3
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      6
      num Events
      5
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      9
      num Events
      4
    7. group Id
      EG006
      num Affected
      9
      num At Risk
      11
      num Events
      9
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      3
      num Events
      2
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      5
      num Events
      2
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      3
      num Events
      1
    11. group Id
      EG010
      num Affected
      3
      num At Risk
      4
      num Events
      3
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      4
      num Events
      3
    term
    Fatigue
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
      num Events
      1
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      11
      num Events
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Asthenia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
      num Events
      1
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      11
      num Events
      1
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      3
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      3
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Pyrexia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      4
      num Events
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      3
      num Events
      2
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      6
      num Events
      3
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      9
      num Events
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      11
      num Events
      1
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      3
      num Events
      2
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      5
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      4
      num Events
      1
    12. group Id
      EG011
      num Affected
      2
      num At Risk
      4
      num Events
      2
    term
    Decreased Appetite
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      5
      num Events
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Hyponatremia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      3
      num Events
      2
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      6
      num Events
      2
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      9
      num Events
      2
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      11
      num Events
      2
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      3
      num Events
      1
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      5
      num Events
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      4
      num Events
      2
    12. group Id
      EG011
      num Affected
      2
      num At Risk
      4
      num Events
      2
    term
    Headache
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      9
      num Events
      2
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      11
      num Events
      2
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      3
      num Events
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      4
      num Events
      1
    term
    Dizziness
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      9
      num Events
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    hypotension
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    thrombocytopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Nausea
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Vomitting
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Pulmonary Embolism
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      5
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    AKI
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      5
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    hypercalcemia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Subarachnoid Hemorrhage
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Subdural Hemorrhage
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Constipation
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      11
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      4
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Hyponatraemia
time Frame
From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days

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

Preserved source evidence · Not medical advice