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NCT00003702 · OUTCOME

Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 2.0

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.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Prior to study entry, weekly during treatment, up to 12 months after normal titer, an average of 7 months.

What was measured

Number of participants with a maximum grade of 3 or higher during the treatment period.

Analysis population: Eligible and treated patients

Groups in this outcome

Arm 1: Methotrexate 30 mg/m2 IM Weekly

Arm 1: Methotrexate 30 mg/m2 IM weekly

Arm 2: Dactinomycin 1.25 mg/m2 IV Push Every 2 Weeks

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

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

Analysis denominator · Participants

GroupSource count
Arm 1: Methotrexate 30 mg/m2 IM Weekly107
Arm 2: Dactinomycin 1.25 mg/m2 IV Push Every 2 Weeks109

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1: Methotrexate 30 mg/m2 IM Weekly14Not reportedNot reportedNot reportedNot reported
Arm 2: Dactinomycin 1.25 mg/m2 IV Push Every 2 Weeks20Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        14
      2. group Id
        OG001
        value
        20
denoms
  1. counts
    1. group Id
      OG000
      value
      107
    2. group Id
      OG001
      value
      109
    units
    Participants
description
Number of participants with a maximum grade of 3 or higher during the treatment period.
groups
  1. description
    Arm 1: Methotrexate 30 mg/m2 IM weekly
    id
    OG000
    title
    Arm 1: Methotrexate 30 mg/m2 IM Weekly
  2. description
    Arm 2: Dactinomycin 1.25 mg/m2 IV push every 2 weeks
    id
    OG001
    title
    Arm 2: Dactinomycin 1.25 mg/m2 IV Push Every 2 Weeks
param Type
COUNT_OF_PARTICIPANTS
population Description
Eligible and treated patients
reporting Status
POSTED
time Frame
Prior to study entry, weekly during treatment, up to 12 months after normal titer, an average of 7 months.
title
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 2.0
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice