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NCT00954174 · OUTCOME

Incidence of Adverse Events as Assessed by CTCAE Version 3.0

Paclitaxel and Carboplatin or Ifosfamide in Treating Patients With Newly Diagnosed, Persistent or Recurrent Uterine, Ovarian, Fallopian Tube, or Peritoneal Cavity Cancer · Source last updated 2021-09-30

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
Patients were assessed for adverse events during active protocol treatment and up to 30 days after the last cycle of treatment on the protocol.

What was measured

Maximum grade experienced among all treated and eligible patients. The grades are described by severity. Grade 1 is the lowest (most mild) and Grade 5 being death (most severe). Adverse events were analyzed across cohorts since disease site was considered independent of AEs.

Analysis population: Treated and Eligible subjects. Adverse events were analyzed across cohorts since disease site was considered independent of AEs.

Groups in this outcome

Regimen I - Uterine and Non-Uterine Subjects

Paclitaxel 175 mg/m2 IV over 3 hours Day 1 Carboplatin (AUC=6) IV Day 1 Repeat q 3 weeks x 6-10 cycles

Regimen II - All Uterine and Non-Uterine Subjects

Ifosfamide 1.6 g/m2 IV days 1, 2, 3 Mesna Paclitaxel 135 mg/m2 by 3-hour infusion on Day 1 Repeat q 3 weeks x 6-10 cycles. G-CSF Support: Filgrastim or Pegfilgrastim beginning Day 4-6

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 - Uterine and Non-Uterine Subjects268
Regimen II - All Uterine and Non-Uterine Subjects247

Reported measurements

Grade 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Regimen I - Uterine and Non-Uterine Subjects3Not reportedNot reportedNot reportedNot reported
Regimen II - All Uterine and Non-Uterine Subjects3Not reportedNot reportedNot reportedNot reported
Grade 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Regimen I - Uterine and Non-Uterine Subjects22Not reportedNot reportedNot reportedNot reported
Regimen II - All Uterine and Non-Uterine Subjects80Not reportedNot reportedNot reportedNot reported
Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Regimen I - Uterine and Non-Uterine Subjects107Not reportedNot reportedNot reportedNot reported
Regimen II - All Uterine and Non-Uterine Subjects97Not reportedNot reportedNot reportedNot reported
Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Regimen I - Uterine and Non-Uterine Subjects130Not reportedNot reportedNot reportedNot reported
Regimen II - All Uterine and Non-Uterine Subjects61Not reportedNot reportedNot reportedNot reported
Grade 5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Regimen I - Uterine and Non-Uterine Subjects6Not reportedNot reportedNot reportedNot reported
Regimen II - All Uterine and Non-Uterine Subjects3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
    title
    Grade 1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        22
      2. group Id
        OG001
        value
        80
    title
    Grade 2
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        107
      2. group Id
        OG001
        value
        97
    title
    Grade 3
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        130
      2. group Id
        OG001
        value
        61
    title
    Grade 4
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        3
    title
    Grade 5
denoms
  1. counts
    1. group Id
      OG000
      value
      268
    2. group Id
      OG001
      value
      247
    units
    Participants
description
Maximum grade experienced among all treated and eligible patients. The grades are described by severity. Grade 1 is the lowest (most mild) and Grade 5 being death (most severe). Adverse events were analyzed across cohorts since disease site was considered independent of AEs.
groups
  1. description
    Paclitaxel 175 mg/m2 IV over 3 hours Day 1 Carboplatin (AUC=6) IV Day 1 Repeat q 3 weeks x 6-10 cycles
    id
    OG000
    title
    Regimen I - Uterine and Non-Uterine Subjects
  2. description
    Ifosfamide 1.6 g/m2 IV days 1, 2, 3 Mesna Paclitaxel 135 mg/m2 by 3-hour infusion on Day 1 Repeat q 3 weeks x 6-10 cycles. G-CSF Support: Filgrastim or Pegfilgrastim beginning Day 4-6
    id
    OG001
    title
    Regimen II - All Uterine and Non-Uterine Subjects
param Type
COUNT_OF_PARTICIPANTS
population Description
Treated and Eligible subjects. Adverse events were analyzed across cohorts since disease site was considered independent of AEs.
reporting Status
POSTED
time Frame
Patients were assessed for adverse events during active protocol treatment and up to 30 days after the last cycle of treatment on the protocol.
title
Incidence of Adverse Events as Assessed by CTCAE Version 3.0
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice