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NCT03397394 · ADVERSE EVENTS

Adverse events

Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma · Source last updated 2023-06-09

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 for each patient were reported from the first dose until 28 days after last dose of study drug, and the total study time for adverse event reporting was approximately 19 months.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
HRD Unknown

Patients with HRD status unknown who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor genome-wide LOH was not tested or not determined were considered HRD unknown.

20 / 4745 / 479 / 47
HRD Negative

Patients with HRD status negative who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor had genome-wide LOH \< 10% were considered HRD-negative.

14 / 3029 / 308 / 30
HRD Positive

Patients with HRD status positive who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor had genome-wide LOH ≥ 10% were considered HRD-positive.

11 / 2019 / 207 / 20
Overall

All patients

45 / 9793 / 9724 / 97

Group identifiers: EG000: HRD Unknown · EG001: HRD Negative · EG002: HRD Positive · EG003: Overall

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 (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      97
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      97
    term
    Pancytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      97
    term
    Cardiac arrest
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      97
    term
    Myocardial infarction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      97
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      97
    term
    Gastric ulcer perforation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      97
    term
    Gastrointestinal haemorrhage
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      97
    term
    Intestinal obstruction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      97
    term
    Small intestinal obstruction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      97
    term
    Disease progression
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      97
    term
    General physical health deterioration
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      97
    term
    Pain

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 (20.1)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      34
      num At Risk
      97
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      97
    term
    Leukocytosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      97
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      14
      num At Risk
      97
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      97
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      97
    term
    Abdominal pain upper
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      97
    term
    Anorectal discomfort
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      97
    term
    Colitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      20
      num At Risk
      97
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      97
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      97
    term
    Dyspepsia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      97
    term
    Dysphagia
Complete source fields
event Groups
  1. deaths Num Affected
    9
    deaths Num At Risk
    47
    description
    Patients with HRD status unknown who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor genome-wide LOH was not tested or not determined were considered HRD unknown.
    id
    EG000
    other Num Affected
    45
    other Num At Risk
    47
    serious Num Affected
    20
    serious Num At Risk
    47
    title
    HRD Unknown
  2. deaths Num Affected
    8
    deaths Num At Risk
    30
    description
    Patients with HRD status negative who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor had genome-wide LOH \< 10% were considered HRD-negative.
    id
    EG001
    other Num Affected
    29
    other Num At Risk
    30
    serious Num Affected
    14
    serious Num At Risk
    30
    title
    HRD Negative
  3. deaths Num Affected
    7
    deaths Num At Risk
    20
    description
    Patients with HRD status positive who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor had genome-wide LOH ≥ 10% were considered HRD-positive.
    id
    EG002
    other Num Affected
    19
    other Num At Risk
    20
    serious Num Affected
    11
    serious Num At Risk
    20
    title
    HRD Positive
  4. deaths Num Affected
    24
    deaths Num At Risk
    97
    description
    All patients
    id
    EG003
    other Num Affected
    93
    other Num At Risk
    97
    serious Num Affected
    45
    serious Num At Risk
    97
    title
    Overall
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      34
      num At Risk
      97
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      97
    term
    Leukocytosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      97
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      14
      num At Risk
      97
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      97
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      97
    term
    Abdominal pain upper
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      97
    term
    Anorectal discomfort
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      97
    term
    Colitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      20
      num At Risk
      97
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      97
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      97
    term
    Dyspepsia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      97
    term
    Dysphagia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      97
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      97
    term
    Pancytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      97
    term
    Cardiac arrest
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      97
    term
    Myocardial infarction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      97
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      97
    term
    Gastric ulcer perforation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      97
    term
    Gastrointestinal haemorrhage
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      97
    term
    Intestinal obstruction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      97
    term
    Small intestinal obstruction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      97
    term
    Disease progression
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      97
    term
    General physical health deterioration
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (20.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      97
    term
    Pain
time Frame
Adverse events for each patient were reported from the first dose until 28 days after last dose of study drug, and the total study time for adverse event reporting was approximately 19 months.

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Preserved source evidence · Not medical advice