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NCT01327885 · ADVERSE EVENTS

Adverse events

Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Dacarbazine in Subjects With Soft Tissue Sarcoma · Source last updated 2023-06-22

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
From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A: Eribulin Mesylate

Eribulin mesylate at a dose of 1.4 mg/m\^2 was administered IV as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.

76 / 228224 / 228198 / 228
Arm B: Dacarbazine

Dacarbazine at a dose of 850 mg/m\^2, 1000 mg/m\^2, or 1200 mg/m\^2 (as selected by the Principal Investigator \[PI\] or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.

71 / 224218 / 224206 / 224

Group identifiers: EG000: Arm A: Eribulin Mesylate · EG001: Arm B: Dacarbazine

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
      11
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      224
    term
    Neutropenia
  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
      228
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      224
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      224
    term
    Leukopenia
  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
      228
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      224
    term
    Febrile 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
      1
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      224
    term
    Lymphopenia
  6. 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
      228
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      224
    term
    Pancytopenia
  7. 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
      228
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      224
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      224
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      224
    term
    Pericardial effusion
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      224
    term
    Cardiac arrest
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      224
    term
    Abdominal pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      224
    term
    Intestinal obstruction

Other reported adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      95
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      51
      num At Risk
      224
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      66
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      68
      num At Risk
      224
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      60
      num At Risk
      224
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      224
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      224
    term
    Lacrimation increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      91
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      106
      num At Risk
      224
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      70
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      58
      num At Risk
      224
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      224
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      224
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      224
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      224
    term
    Stomatitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      224
    term
    Abdominal pain upper
Complete source fields
event Groups
  1. deaths Num Affected
    198
    deaths Num At Risk
    228
    description
    Eribulin mesylate at a dose of 1.4 mg/m\^2 was administered IV as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.
    id
    EG000
    other Num Affected
    224
    other Num At Risk
    228
    serious Num Affected
    76
    serious Num At Risk
    228
    title
    Arm A: Eribulin Mesylate
  2. deaths Num Affected
    206
    deaths Num At Risk
    224
    description
    Dacarbazine at a dose of 850 mg/m\^2, 1000 mg/m\^2, or 1200 mg/m\^2 (as selected by the Principal Investigator \[PI\] or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
    id
    EG001
    other Num Affected
    218
    other Num At Risk
    224
    serious Num Affected
    71
    serious Num At Risk
    224
    title
    Arm B: Dacarbazine
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
      95
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      51
      num At Risk
      224
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      66
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      68
      num At Risk
      224
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      60
      num At Risk
      224
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      224
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      224
    term
    Lacrimation increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      91
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      106
      num At Risk
      224
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      70
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      58
      num At Risk
      224
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      224
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      224
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      224
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      224
    term
    Stomatitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      224
    term
    Abdominal pain upper
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
      11
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      224
    term
    Neutropenia
  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
      228
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      224
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      224
    term
    Leukopenia
  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
      228
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      224
    term
    Febrile 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
      1
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      224
    term
    Lymphopenia
  6. 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
      228
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      224
    term
    Pancytopenia
  7. 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
      228
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      224
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      224
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      224
    term
    Pericardial effusion
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      224
    term
    Cardiac arrest
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      224
    term
    Abdominal pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      224
    term
    Intestinal obstruction
time Frame
From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months

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