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NCT01282463 · ADVERSE EVENTS

Adverse events

Study of Ramucirumab or Icrucumab (IMC-18F1) With Docetaxel or Docetaxel Alone as Second-Line Therapy in Participants With Bladder,Urethra, Ureter, or Renal Pelvis Carcinoma · Source last updated 2019-09-09

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
Not reported
Other-event reporting threshold
5%

All randomized participants who received at least one dose of study drug.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Docetaxel

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal. Docetaxel: Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

19 / 4545 / 45Not reported / Not reported
Docetaxel + Ramucirumab DP

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal. Docetaxel: Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle Ramucirumab DP: Ramucirumab (DP): 10 mg/kg IV on day 1 of each 21-day cycle

25 / 4646 / 46Not reported / Not reported
Docetaxel + Icrucumab

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal. Docetaxel: Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle

22 / 4949 / 49Not reported / Not reported

Group identifiers: EG000: Docetaxel · EG001: Docetaxel + Ramucirumab DP · EG002: Docetaxel + Icrucumab

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 17.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      45
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      46
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      49
      num Events
      2
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      45
      num Events
      6
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      46
      num Events
      9
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      49
      num Events
      3
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      45
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      46
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      49
      num Events
      1
    term
    Haemorrhagic anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      45
      num Events
      3
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      46
      num Events
      4
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      49
      num Events
      2
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      45
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      46
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
      num Events
      0
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      46
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      49
      num Events
      2
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      46
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
      num Events
      0
    term
    Cardio-respiratory arrest
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      45
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      46
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      49
      num Events
      1
    term
    Left ventricular dysfunction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      45
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      46
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      49
      num Events
      1
    term
    Pericardial effusion
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      46
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      49
      num Events
      1
    term
    Tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      45
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      46
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
      num Events
      0
    term
    Ascites
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      45
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      46
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
      num Events
      0
    term
    Constipation

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 17.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      45
      num Events
      14
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      46
      num Events
      44
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      49
      num Events
      49
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      45
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      46
      num Events
      2
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      49
      num Events
      14
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      45
      num Events
      18
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      46
      num Events
      15
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      49
      num Events
      25
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      45
      num Events
      8
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      46
      num Events
      23
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      49
      num Events
      4
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      45
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      46
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      49
      num Events
      1
    term
    Tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      45
      num Events
      3
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      46
      num Events
      18
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      49
      num Events
      5
    term
    Lacrimation increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      45
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      46
      num Events
      2
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      49
      num Events
      5
    term
    Vision blurred
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      46
      num Events
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      49
      num Events
      3
    term
    Abdominal discomfort
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      45
      num Events
      5
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      46
      num Events
      11
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      49
      num Events
      6
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      45
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      46
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
      num Events
      0
    term
    Abdominal pain lower
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      45
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      46
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      49
      num Events
      3
    term
    Abdominal pain upper
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      45
      num Events
      14
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      46
      num Events
      12
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      49
      num Events
      17
    term
    Constipation
Complete source fields
description
All randomized participants who received at least one dose of study drug.
event Groups
  1. description
    Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal. Docetaxel: Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle
    id
    EG000
    other Num Affected
    45
    other Num At Risk
    45
    serious Num Affected
    19
    serious Num At Risk
    45
    title
    Docetaxel
  2. description
    Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal. Docetaxel: Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle Ramucirumab DP: Ramucirumab (DP): 10 mg/kg IV on day 1 of each 21-day cycle
    id
    EG001
    other Num Affected
    46
    other Num At Risk
    46
    serious Num Affected
    25
    serious Num At Risk
    46
    title
    Docetaxel + Ramucirumab DP
  3. description
    Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal. Docetaxel: Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle
    id
    EG002
    other Num Affected
    49
    other Num At Risk
    49
    serious Num Affected
    22
    serious Num At Risk
    49
    title
    Docetaxel + Icrucumab
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      45
      num Events
      14
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      46
      num Events
      44
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      49
      num Events
      49
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      45
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      46
      num Events
      2
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      49
      num Events
      14
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      45
      num Events
      18
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      46
      num Events
      15
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      49
      num Events
      25
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      45
      num Events
      8
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      46
      num Events
      23
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      49
      num Events
      4
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      45
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      46
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      49
      num Events
      1
    term
    Tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      45
      num Events
      3
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      46
      num Events
      18
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      49
      num Events
      5
    term
    Lacrimation increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      45
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      46
      num Events
      2
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      49
      num Events
      5
    term
    Vision blurred
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      46
      num Events
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      49
      num Events
      3
    term
    Abdominal discomfort
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      45
      num Events
      5
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      46
      num Events
      11
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      49
      num Events
      6
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      45
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      46
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
      num Events
      0
    term
    Abdominal pain lower
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      45
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      46
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      49
      num Events
      3
    term
    Abdominal pain upper
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      45
      num Events
      14
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      46
      num Events
      12
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      49
      num Events
      17
    term
    Constipation
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      45
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      46
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      49
      num Events
      2
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      45
      num Events
      6
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      46
      num Events
      9
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      49
      num Events
      3
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      45
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      46
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      49
      num Events
      1
    term
    Haemorrhagic anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      45
      num Events
      3
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      46
      num Events
      4
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      49
      num Events
      2
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      45
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      46
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
      num Events
      0
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      46
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      49
      num Events
      2
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      46
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
      num Events
      0
    term
    Cardio-respiratory arrest
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      45
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      46
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      49
      num Events
      1
    term
    Left ventricular dysfunction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      45
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      46
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      49
      num Events
      1
    term
    Pericardial effusion
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      46
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      49
      num Events
      1
    term
    Tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      45
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      46
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
      num Events
      0
    term
    Ascites
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      45
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      46
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
      num Events
      0
    term
    Constipation

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Preserved source evidence · Not medical advice