Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01535053 · OUTCOME

Percentage of Participants With Complete Response

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
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
hCG testing is performed prior to each cycle to treatment until treatment is completed, up to 10 months. For patients who have responded to treatment hCG must be obtained every 4 weeks for 1 year after completing treatment.

What was measured

Complete Response is defined as 3 consecutive bi-weekly values of hCG\<5 over a minimum of 4 weeks of normal hCG values with no values greater than 5 mIU/ml

Analysis population: Eligible 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

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Regimen I (Dactinomycin)78.6Not reported59.091.7Not reported
Regimen II (Methotrexate)88.5Not reported69.897.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        59.0
        upper Limit
        91.7
        value
        78.6
      2. group Id
        OG001
        lower Limit
        69.8
        upper Limit
        97.6
        value
        88.5
denoms
  1. counts
    1. group Id
      OG000
      value
      28
    2. group Id
      OG001
      value
      26
    units
    Participants
description
Complete Response is defined as 3 consecutive bi-weekly values of hCG\<5 over a minimum of 4 weeks of normal hCG values with no values greater than 5 mIU/ml
dispersion Type
95% Confidence Interval
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 patients
reporting Status
POSTED
time Frame
hCG testing is performed prior to each cycle to treatment until treatment is completed, up to 10 months. For patients who have responded to treatment hCG must be obtained every 4 weeks for 1 year after completing treatment.
title
Percentage of Participants With Complete Response
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice