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NCT01535053 · ADVERSE EVENTS

Adverse events

Dactinomycin or Methotrexate in Treating Patients With Low-Risk Gestational Trophoblastic Neoplasia · Source last updated 2022-08-12

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 Treatment and up to 30 days after discontinuing treatment.
Other-event reporting threshold
0%

Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Regimen I (Dactinomycin)

IV pulse actinomycin-D (1.25mg/m2 ) every 14 days. (2mg max dose)

1 / 2827 / 280 / 29
Regimen II (Methotrexate)

institutional preference of either: * IV methotrexate (0.4 mg/kg) daily for 5 days every 14 days. (25mg max daily dose) OR * IM methotrexate (50mg) on Days 1, 3, 5, 7 (4 doses per cycle) with Leucovorin (15mg) on Days 2, 4, 6, 8. Repeat every 14 days.

1 / 2624 / 260 / 28

Group identifiers: EG000: Regimen I (Dactinomycin) · EG001: Regimen II (Methotrexate)

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
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
    term
    Appendicitis
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
    term
    Psychiatric Disorders - Other

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 (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
    term
    Lymph Node Pain
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      26
    term
    Blood And Lymphatic System Disorders - Other
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      26
    term
    Anemia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
    term
    Palpitations
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
    term
    Cardiac Disorders - Other
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      26
    term
    Tinnitus
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
    term
    Hearing Impaired
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
    term
    Ear Pain
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      26
    term
    Eye Disorders - Other
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      26
    term
    Watering Eyes
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
    term
    Eye Pain
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
    term
    Photophobia
Complete source fields
description
Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    29
    description
    IV pulse actinomycin-D (1.25mg/m2 ) every 14 days. (2mg max dose)
    id
    EG000
    other Num Affected
    27
    other Num At Risk
    28
    serious Num Affected
    1
    serious Num At Risk
    28
    title
    Regimen I (Dactinomycin)
  2. deaths Num Affected
    0
    deaths Num At Risk
    28
    description
    institutional preference of either: * IV methotrexate (0.4 mg/kg) daily for 5 days every 14 days. (25mg max daily dose) OR * IM methotrexate (50mg) on Days 1, 3, 5, 7 (4 doses per cycle) with Leucovorin (15mg) on Days 2, 4, 6, 8. Repeat every 14 days.
    id
    EG001
    other Num Affected
    24
    other Num At Risk
    26
    serious Num Affected
    1
    serious Num At Risk
    26
    title
    Regimen II (Methotrexate)
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
    term
    Lymph Node Pain
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      26
    term
    Blood And Lymphatic System Disorders - Other
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      26
    term
    Anemia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
    term
    Palpitations
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
    term
    Cardiac Disorders - Other
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      26
    term
    Tinnitus
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
    term
    Hearing Impaired
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
    term
    Ear Pain
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      26
    term
    Eye Disorders - Other
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      26
    term
    Watering Eyes
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
    term
    Eye Pain
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
    term
    Photophobia
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
    term
    Appendicitis
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
    term
    Psychiatric Disorders - Other
time Frame
Through Study Treatment and up to 30 days after discontinuing treatment.

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Preserved source evidence · Not medical advice