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NCT02489903 · ADVERSE EVENTS

Adverse events

RRx-001 in Lung Cancer, Ovarian Cancer and Neuroendocrine Tumors Prior to Re-administration of Platinum Based Doublet Regimens (QUADRUPLE THREAT) · Source last updated 2025-03-17

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
Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug.
Other-event reporting threshold
5%

All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
RRx-001 + Platinum Doublet (A01-09)

4mg RRx-001 once weekly (QW) until progression, followed by up to 6 cycles of platinum doublet chemotherapy

55 / 8989 / 8989 / 89
RRx-001 + Platinum + RRx-001 (A10)

RRx-001 weekly for 3 weeks followed by up to 6 cycles of platinum doublet chemotherapy and then RRx-001 maintenance (for patients with stable disease (SD) or better at discontinuation of platinum).

6 / 1010 / 1010 / 10
Investigator's Choice (A10)

Standard of Care Investigator's Choice Control Arm, treatment options of one of the following: carboplatin, etoposide, doxil, gemcitabine, vinorelbine or taxane treatments until progression or intolerable toxicity

2 / 22 / 22 / 2

Group identifiers: EG000: RRx-001 + Platinum Doublet (A01-09) · EG001: RRx-001 + Platinum + RRx-001 (A10) · EG002: Investigator's Choice (A10)

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      89
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Febrile Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      89
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Supraventricular Tachycardia (SVT)
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Cushing's Syndrome
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      89
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Abdominal Pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Abdominal Pain upper
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Ascites
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      89
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Duodenal Obstruction

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      89
      num Events
      27
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      10
      num Events
      8
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      2
      num Events
      2
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      89
      num Events
      13
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      10
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      89
      num Events
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Decreased appetite
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      89
      num Events
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Tumour pseudoprogression
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      89
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Mental status changes
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      89
      num Events
      12
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      10
      num Events
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      89
      num Events
      12
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      10
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      89
      num Events
      23
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      10
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      89
      num Events
      25
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      10
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      89
      num Events
      13
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      10
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      89
      num Events
      35
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      10
      num Events
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      89
      num Events
      18
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      10
      num Events
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Infusion related reaction
Complete source fields
description
All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
event Groups
  1. deaths Num Affected
    89
    deaths Num At Risk
    89
    description
    4mg RRx-001 once weekly (QW) until progression, followed by up to 6 cycles of platinum doublet chemotherapy
    id
    EG000
    other Num Affected
    89
    other Num At Risk
    89
    serious Num Affected
    55
    serious Num At Risk
    89
    title
    RRx-001 + Platinum Doublet (A01-09)
  2. deaths Num Affected
    10
    deaths Num At Risk
    10
    description
    RRx-001 weekly for 3 weeks followed by up to 6 cycles of platinum doublet chemotherapy and then RRx-001 maintenance (for patients with stable disease (SD) or better at discontinuation of platinum).
    id
    EG001
    other Num Affected
    10
    other Num At Risk
    10
    serious Num Affected
    6
    serious Num At Risk
    10
    title
    RRx-001 + Platinum + RRx-001 (A10)
  3. deaths Num Affected
    2
    deaths Num At Risk
    2
    description
    Standard of Care Investigator's Choice Control Arm, treatment options of one of the following: carboplatin, etoposide, doxil, gemcitabine, vinorelbine or taxane treatments until progression or intolerable toxicity
    id
    EG002
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    2
    serious Num At Risk
    2
    title
    Investigator's Choice (A10)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      89
      num Events
      27
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      10
      num Events
      8
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      2
      num Events
      2
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      89
      num Events
      13
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      10
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      89
      num Events
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Decreased appetite
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      89
      num Events
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Tumour pseudoprogression
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      89
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Mental status changes
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      89
      num Events
      12
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      10
      num Events
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      89
      num Events
      12
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      10
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      89
      num Events
      23
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      10
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      89
      num Events
      25
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      10
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      89
      num Events
      13
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      10
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      89
      num Events
      35
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      10
      num Events
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      89
      num Events
      18
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      10
      num Events
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Infusion related reaction
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      89
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Febrile Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      89
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Supraventricular Tachycardia (SVT)
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Cushing's Syndrome
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      89
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Abdominal Pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Abdominal Pain upper
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Ascites
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      89
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      89
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Duodenal Obstruction
time Frame
Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug.

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Preserved source evidence · Not medical advice