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NCT00416624 · ADVERSE EVENTS

Adverse events

Epoetin Alfa or Darbepoetin Alfa in Treating Patients With Anemia Caused by Chemotherapy · Source last updated 2017-02-10

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
16 Weeks
Other-event reporting threshold
0%

All evaluable patients per protocol that reported at least one value after baseline.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Epoetin Alfa - 40k Weekly

Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)

4 / 6021 / 60Not reported / Not reported
Epoetin Alfa - 80k Every 3 Weeks

Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)

7 / 6016 / 60Not reported / Not reported
Epoetin Alfa - 120k Every 3 Weeks

Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)

4 / 5816 / 58Not reported / Not reported
Darbepoetin Alfa - 500 mcg Every 3 Weeks

Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)

2 / 567 / 56Not reported / Not reported

Group identifiers: EG000: Epoetin Alfa - 40k Weekly · EG001: Epoetin Alfa - 80k Every 3 Weeks · EG002: Epoetin Alfa - 120k Every 3 Weeks · EG003: Darbepoetin Alfa - 500 mcg Every 3 Weeks

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 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      60
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      60
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Diarrhea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      60
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Rectal stenosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      60
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      60
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Disease progression
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      60
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Sudden death
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      60
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Pneumonia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      60
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Neutrophil count decreased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      60
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Anorexia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      60
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Dehydration
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      60
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Hyponatremia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      60
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Muscle weakness
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      60
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      56
      num Events
      1
    term
    Dizziness

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 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      60
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      60
      num Events
      6
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      58
      num Events
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      56
      num Events
      3
    term
    Hemoglobin decreased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      60
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Atrial flutter
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      60
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      56
      num Events
      1
    term
    Atrial tachycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      60
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      56
      num Events
      1
    term
    Left ventricular failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      60
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Myocardial ischemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      60
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Extraocular muscle paresis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      60
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      60
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Colonic hemorrhage
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      60
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      60
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      60
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      58
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Diarrhea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      60
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Dysphagia
Complete source fields
description
All evaluable patients per protocol that reported at least one value after baseline.
event Groups
  1. description
    Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
    id
    EG000
    other Num Affected
    21
    other Num At Risk
    60
    serious Num Affected
    4
    serious Num At Risk
    60
    title
    Epoetin Alfa - 40k Weekly
  2. description
    Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
    id
    EG001
    other Num Affected
    16
    other Num At Risk
    60
    serious Num Affected
    7
    serious Num At Risk
    60
    title
    Epoetin Alfa - 80k Every 3 Weeks
  3. description
    Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
    id
    EG002
    other Num Affected
    16
    other Num At Risk
    58
    serious Num Affected
    4
    serious Num At Risk
    58
    title
    Epoetin Alfa - 120k Every 3 Weeks
  4. description
    Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
    id
    EG003
    other Num Affected
    7
    other Num At Risk
    56
    serious Num Affected
    2
    serious Num At Risk
    56
    title
    Darbepoetin Alfa - 500 mcg Every 3 Weeks
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      60
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      60
      num Events
      6
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      58
      num Events
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      56
      num Events
      3
    term
    Hemoglobin decreased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      60
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Atrial flutter
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      60
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      56
      num Events
      1
    term
    Atrial tachycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      60
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      56
      num Events
      1
    term
    Left ventricular failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      60
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Myocardial ischemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      60
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Extraocular muscle paresis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      60
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      60
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Colonic hemorrhage
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      60
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      60
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      60
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      58
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Diarrhea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      60
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Dysphagia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      60
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      60
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Diarrhea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      60
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Rectal stenosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      60
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      60
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Disease progression
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      60
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Sudden death
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      60
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Pneumonia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      60
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Neutrophil count decreased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      60
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Anorexia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      60
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Dehydration
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      60
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Hyponatremia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      60
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      56
      num Events
      0
    term
    Muscle weakness
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 9
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      60
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      56
      num Events
      1
    term
    Dizziness
time Frame
16 Weeks

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Preserved source evidence · Not medical advice