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NCT00003702 · ADVERSE EVENTS

Adverse events

Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia · Source last updated 2018-05-15

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
Through Study completion, an average of 7 months.
Other-event reporting threshold
0%

The frequencies of any serious adverse event or other adverse events (grade 2 or higher) by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported. Adverse events were collected by Organ System Class.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm 1: Methotrexate 30 mg/m2 IM Weekly

Arm 1: Methotrexate 30 mg/m2 IM weekly

0 / 10750 / 107Not reported / Not reported
Arm 2: Dactinomycin 1.25 mg/m2 IV Push Every 2 Weeks

Arm 2: Dactinomycin 1.25 mg/m2 IV push every 2 weeks

1 / 10768 / 107Not reported / Not reported

Group identifiers: EG000: Arm 1: Methotrexate 30 mg/m2 IM Weekly · EG001: Arm 2: Dactinomycin 1.25 mg/m2 IV Push Every 2 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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      107
    term
    Dyspnea

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      107
    term
    Leukopenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      107
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      107
    term
    Thrombocytopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      107
    term
    Anemia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      107
    term
    Other Hemotologic
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      107
    term
    Allergy
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      107
    term
    Auditory
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      107
    term
    Cardiovascular
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      107
    term
    Coagulation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      107
    term
    Constitutional
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      107
    term
    Dermatologic
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      107
    term
    Endocrine
Complete source fields
description
The frequencies of any serious adverse event or other adverse events (grade 2 or higher) by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported. Adverse events were collected by Organ System Class.
event Groups
  1. description
    Arm 1: Methotrexate 30 mg/m2 IM weekly
    id
    EG000
    other Num Affected
    50
    other Num At Risk
    107
    serious Num Affected
    0
    serious Num At Risk
    107
    title
    Arm 1: Methotrexate 30 mg/m2 IM Weekly
  2. description
    Arm 2: Dactinomycin 1.25 mg/m2 IV push every 2 weeks
    id
    EG001
    other Num Affected
    68
    other Num At Risk
    107
    serious Num Affected
    1
    serious Num At Risk
    107
    title
    Arm 2: Dactinomycin 1.25 mg/m2 IV Push Every 2 Weeks
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      107
    term
    Leukopenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      107
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      107
    term
    Thrombocytopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      107
    term
    Anemia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      107
    term
    Other Hemotologic
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      107
    term
    Allergy
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      107
    term
    Auditory
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      107
    term
    Cardiovascular
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      107
    term
    Coagulation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      107
    term
    Constitutional
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      107
    term
    Dermatologic
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      107
    term
    Endocrine
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      107
    term
    Dyspnea
time Frame
Through Study completion, an average of 7 months.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice