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NCT01535053 · OUTCOME

The Number of Participants With Post Protocol Surgical Treatment for Each 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
Anytime during post treatment follow-up for up to 2 years from study entry.

Analysis population: Non-responding eligible patients in follow-up

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)7
Regimen II (Methotrexate)5

Reported measurements

Source class 1
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
        0
      2. group Id
        OG001
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      5
    units
    Participants
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
Non-responding eligible patients in follow-up
reporting Status
POSTED
time Frame
Anytime during post treatment follow-up for up to 2 years from study entry.
title
The Number of Participants With Post Protocol Surgical Treatment for Each Arm.
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice