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NCT01494506 · ADVERSE EVENTS

Adverse events

Study of MM-398 With or Without 5-FU/LV, Versus 5-FU/LV in Patients With Metastatic Pancreatic Cancer · Source last updated 2016-06-17

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
Study drug initiation through 30 days after the last dose of study drug or EOS, whichever is later; Up to 764 days.
Other-event reporting threshold
5%

5-FU= 5-fluorouracil; LV=leucovorin Events were collected by systematic assessment Term from vocabulary, MedDRA version 14.1

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
MM-398

MM-398 Q3W IV MM-398: Arm A: MM-398 120 mg/m2 IV Q3W Arm C: MM-398 80mg/m2 IV Q2W

90 / 147145 / 147Not reported / Not reported
5 Fluorouracil and Leucovorin IV

5 Fluorouracil and Leucovorin IV 5 Fluorouracil: Arm B: 5 Fluorouracil 2000 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks Arm C: 5 Fluorouracil 2400 mg/m2 IV every 2 weeks Leucovorin: Arm B: Leucovorin 200 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks Arm C: Leucovorin 400 mg/m2 IV every 2 weeks

58 / 134132 / 134Not reported / Not reported
MM-398, 5-FU and Leucovorin

MM-398, 5-FU and Leucovorin Q2W IV MM-398: Arm A: MM-398 120 mg/m2 IV Q3W Arm C: MM-398 80mg/m2 IV Q2W 5 Fluorouracil: Arm B: 5 Fluorouracil 2000 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks Arm C: 5 Fluorouracil 2400 mg/m2 IV every 2 weeks Leucovorin: Arm B: Leucovorin 200 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks Arm C: Leucovorin 400 mg/m2 IV every 2 weeks

56 / 117116 / 117Not reported / Not reported

Group identifiers: EG000: MM-398 · EG001: 5 Fluorouracil and Leucovorin IV · EG002: MM-398, 5-FU and Leucovorin

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 (14.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      147
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      117
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.1)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      147
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      117
    term
    Febrile Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      147
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      117
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      147
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      117
    term
    Pancytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.1)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      147
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      117
    term
    Abdominal Pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      147
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      117
    term
    Abdominal Pain Upper
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      147
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      117
    term
    Ascites
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.1)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      147
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      117
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      147
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      117
    term
    Duodenal Ulcer
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      147
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      117
    term
    Gastro Intestinal Haemorrhage
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      147
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      117
    term
    Intestinal Obstruction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      147
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      117
    term
    Nausea

Other reported adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.1)
    stats
    1. group Id
      EG000
      num Affected
      103
      num At Risk
      147
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      116
      num At Risk
      117
    term
    Diarrhoea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.1)
    stats
    1. group Id
      EG000
      num Affected
      80
      num At Risk
      147
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      61
      num At Risk
      117
    term
    Vomiting
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.1)
    stats
    1. group Id
      EG000
      num Affected
      89
      num At Risk
      147
    2. group Id
      EG001
      num Affected
      46
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      60
      num At Risk
      117
    term
    Nausea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (14.1)
    stats
    1. group Id
      EG000
      num Affected
      72
      num At Risk
      147
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      52
      num At Risk
      117
    term
    Decreased Appetite
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (14.1)
    stats
    1. group Id
      EG000
      num Affected
      54
      num At Risk
      147
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      47
      num At Risk
      117
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.1)
    stats
    1. group Id
      EG000
      num Affected
      48
      num At Risk
      147
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      44
      num At Risk
      117
    term
    Anaemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.1)
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      147
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      27
      num At Risk
      117
    term
    Abdominal Pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (14.1)
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      147
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      27
      num At Risk
      117
    term
    Pyrexia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.1)
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      147
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      27
      num At Risk
      117
    term
    Neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.1)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      147
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      26
      num At Risk
      117
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.1)
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      147
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      117
    term
    Asthenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (14.1)
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      147
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      117
    term
    Weight Decreased
Complete source fields
description
5-FU= 5-fluorouracil; LV=leucovorin Events were collected by systematic assessment Term from vocabulary, MedDRA version 14.1
event Groups
  1. description
    MM-398 Q3W IV MM-398: Arm A: MM-398 120 mg/m2 IV Q3W Arm C: MM-398 80mg/m2 IV Q2W
    id
    EG000
    other Num Affected
    145
    other Num At Risk
    147
    serious Num Affected
    90
    serious Num At Risk
    147
    title
    MM-398
  2. description
    5 Fluorouracil and Leucovorin IV 5 Fluorouracil: Arm B: 5 Fluorouracil 2000 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks Arm C: 5 Fluorouracil 2400 mg/m2 IV every 2 weeks Leucovorin: Arm B: Leucovorin 200 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks Arm C: Leucovorin 400 mg/m2 IV every 2 weeks
    id
    EG001
    other Num Affected
    132
    other Num At Risk
    134
    serious Num Affected
    58
    serious Num At Risk
    134
    title
    5 Fluorouracil and Leucovorin IV
  3. description
    MM-398, 5-FU and Leucovorin Q2W IV MM-398: Arm A: MM-398 120 mg/m2 IV Q3W Arm C: MM-398 80mg/m2 IV Q2W 5 Fluorouracil: Arm B: 5 Fluorouracil 2000 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks Arm C: 5 Fluorouracil 2400 mg/m2 IV every 2 weeks Leucovorin: Arm B: Leucovorin 200 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks Arm C: Leucovorin 400 mg/m2 IV every 2 weeks
    id
    EG002
    other Num Affected
    116
    other Num At Risk
    117
    serious Num Affected
    56
    serious Num At Risk
    117
    title
    MM-398, 5-FU and Leucovorin
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.1)
    stats
    1. group Id
      EG000
      num Affected
      103
      num At Risk
      147
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      116
      num At Risk
      117
    term
    Diarrhoea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.1)
    stats
    1. group Id
      EG000
      num Affected
      80
      num At Risk
      147
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      61
      num At Risk
      117
    term
    Vomiting
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.1)
    stats
    1. group Id
      EG000
      num Affected
      89
      num At Risk
      147
    2. group Id
      EG001
      num Affected
      46
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      60
      num At Risk
      117
    term
    Nausea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (14.1)
    stats
    1. group Id
      EG000
      num Affected
      72
      num At Risk
      147
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      52
      num At Risk
      117
    term
    Decreased Appetite
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (14.1)
    stats
    1. group Id
      EG000
      num Affected
      54
      num At Risk
      147
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      47
      num At Risk
      117
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.1)
    stats
    1. group Id
      EG000
      num Affected
      48
      num At Risk
      147
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      44
      num At Risk
      117
    term
    Anaemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.1)
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      147
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      27
      num At Risk
      117
    term
    Abdominal Pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (14.1)
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      147
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      27
      num At Risk
      117
    term
    Pyrexia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.1)
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      147
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      27
      num At Risk
      117
    term
    Neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.1)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      147
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      26
      num At Risk
      117
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.1)
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      147
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      117
    term
    Asthenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (14.1)
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      147
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      117
    term
    Weight Decreased
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      147
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      117
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.1)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      147
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      117
    term
    Febrile Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      147
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      117
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      147
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      117
    term
    Pancytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.1)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      147
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      117
    term
    Abdominal Pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      147
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      117
    term
    Abdominal Pain Upper
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      147
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      117
    term
    Ascites
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.1)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      147
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      117
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      147
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      117
    term
    Duodenal Ulcer
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      147
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      117
    term
    Gastro Intestinal Haemorrhage
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      147
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      117
    term
    Intestinal Obstruction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      147
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      117
    term
    Nausea
time Frame
Study drug initiation through 30 days after the last dose of study drug or EOS, whichever is later; Up to 764 days.

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Preserved source evidence · Not medical advice