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NCT01535053 · OUTCOME

Number of Participants With CTCAE v4 Graded Adverse Events With Low-risk Gestational Trophoblastic Neoplasia by Arm

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.

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Assessed throughout the treatment period and within 2-4 weeks after discontinuation of treatment

What was measured

Maximum grade of physician assessed adverse events reported during treatment

Analysis population: Eligible and treated patients

Groups in this outcome

Regimen I (Dactinomycin)

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

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Regimen I (Dactinomycin)28
Regimen II (Methotrexate)26

Reported measurements

Grade 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Regimen I (Dactinomycin)7Not reportedNot reportedNot reportedNot reported
Regimen II (Methotrexate)4Not reportedNot reportedNot reportedNot reported
Grade 2
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Regimen I (Dactinomycin)14Not reportedNot reportedNot reportedNot reported
Regimen II (Methotrexate)10Not reportedNot reportedNot reportedNot reported
Grade 3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Regimen I (Dactinomycin)6Not reportedNot reportedNot reportedNot reported
Regimen II (Methotrexate)10Not reportedNot reportedNot reportedNot reported
Grade 4
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Regimen I (Dactinomycin)0Not reportedNot reportedNot reportedNot reported
Regimen II (Methotrexate)0Not reportedNot reportedNot reportedNot reported
Grade 5
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Regimen I (Dactinomycin)0Not reportedNot reportedNot reportedNot reported
Regimen II (Methotrexate)0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        4
    title
    Grade 1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        14
      2. group Id
        OG001
        value
        10
    title
    Grade 2
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        10
    title
    Grade 3
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Grade 4
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Grade 5
denoms
  1. counts
    1. group Id
      OG000
      value
      28
    2. group Id
      OG001
      value
      26
    units
    Participants
description
Maximum grade of physician assessed adverse events reported during treatment
groups
  1. description
    IV pulse actinomycin-D (1.25mg/m2 ) every 14 days. (2mg max dose)
    id
    OG000
    title
    Regimen I (Dactinomycin)
  2. 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
    OG001
    title
    Regimen II (Methotrexate)
param Type
NUMBER
population Description
Eligible and treated patients
reporting Status
POSTED
time Frame
Assessed throughout the treatment period and within 2-4 weeks after discontinuation of treatment
title
Number of Participants With CTCAE v4 Graded Adverse Events With Low-risk Gestational Trophoblastic Neoplasia by Arm
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice