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NCT00064077 · OUTCOME

Pain, Assessed by Brief Pain Inventory

Comparison of Four Combination Chemotherapy Regimens Using Cisplatin in Treating Patients With Stage IVB, Recurrent, or Persistent Cancer of the Cervix · Source last updated 2018-10-17

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
units on a scale
Interval / dispersion
Standard Deviation
Time frame
Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1

What was measured

Single item from the Brief Pain Inventory (BPI) assessing "worst pain" in the past 24 hours, on a 0-10 scale with a higher score indicating more pain than a low score.

Analysis population: Patients who provided baseline and ≥ one follow-up assessments

Groups in this outcome

Arm I (Paclitaxel, Cisplatin)

Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2. Cisplatin: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies

Arm II (Vinorelbine, Cisplatin)

Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Vinorelbine Tartrate: Given IV

Arm III (Gemcitabine, Cisplatin)

Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II. Cisplatin: Given IV Gemcitabine Hydrochloride Quality-of-Life Assessment: Ancillary studies

Arm IV (Topotecan, Cisplatin)

Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Topotecan Hydrochloride: Given IV

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 I (Paclitaxel, Cisplatin)74
Arm II (Vinorelbine, Cisplatin)83
Arm III (Gemcitabine, Cisplatin)86
Arm IV (Topotecan, Cisplatin)92

Reported measurements

Baseline
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm I (Paclitaxel, Cisplatin)4.02.8Not reportedNot reportedNot reported
Arm II (Vinorelbine, Cisplatin)3.93.2Not reportedNot reportedNot reported
Arm III (Gemcitabine, Cisplatin)3.33.0Not reportedNot reportedNot reported
Arm IV (Topotecan, Cisplatin)3.63.3Not reportedNot reportedNot reported
Pre-cycle 2
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm I (Paclitaxel, Cisplatin)3.52.9Not reportedNot reportedNot reported
Arm II (Vinorelbine, Cisplatin)3.52.8Not reportedNot reportedNot reported
Arm III (Gemcitabine, Cisplatin)3.43.0Not reportedNot reportedNot reported
Arm IV (Topotecan, Cisplatin)3.63.1Not reportedNot reportedNot reported
Pre-cycle 5
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm I (Paclitaxel, Cisplatin)3.63.1Not reportedNot reportedNot reported
Arm II (Vinorelbine, Cisplatin)4.02.7Not reportedNot reportedNot reported
Arm III (Gemcitabine, Cisplatin)3.53.0Not reportedNot reportedNot reported
Arm IV (Topotecan, Cisplatin)2.53.0Not reportedNot reportedNot reported
9 months post cycle 1
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm I (Paclitaxel, Cisplatin)2.33.0Not reportedNot reportedNot reported
Arm II (Vinorelbine, Cisplatin)3.22.9Not reportedNot reportedNot reported
Arm III (Gemcitabine, Cisplatin)3.73.0Not reportedNot reportedNot reported
Arm IV (Topotecan, Cisplatin)2.92.7Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.8
        value
        4.0
      2. group Id
        OG001
        spread
        3.2
        value
        3.9
      3. group Id
        OG002
        spread
        3.0
        value
        3.3
      4. group Id
        OG003
        spread
        3.3
        value
        3.6
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.9
        value
        3.5
      2. group Id
        OG001
        spread
        2.8
        value
        3.5
      3. group Id
        OG002
        spread
        3.0
        value
        3.4
      4. group Id
        OG003
        spread
        3.1
        value
        3.6
    title
    Pre-cycle 2
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.1
        value
        3.6
      2. group Id
        OG001
        spread
        2.7
        value
        4.0
      3. group Id
        OG002
        spread
        3.0
        value
        3.5
      4. group Id
        OG003
        spread
        3.0
        value
        2.5
    title
    Pre-cycle 5
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.0
        value
        2.3
      2. group Id
        OG001
        spread
        2.9
        value
        3.2
      3. group Id
        OG002
        spread
        3.0
        value
        3.7
      4. group Id
        OG003
        spread
        2.7
        value
        2.9
    title
    9 months post cycle 1
denoms
  1. counts
    1. group Id
      OG000
      value
      74
    2. group Id
      OG001
      value
      83
    3. group Id
      OG002
      value
      86
    4. group Id
      OG003
      value
      92
    units
    Participants
description
Single item from the Brief Pain Inventory (BPI) assessing "worst pain" in the past 24 hours, on a 0-10 scale with a higher score indicating more pain than a low score.
dispersion Type
Standard Deviation
groups
  1. description
    Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2. Cisplatin: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies
    id
    OG000
    title
    Arm I (Paclitaxel, Cisplatin)
  2. description
    Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Vinorelbine Tartrate: Given IV
    id
    OG001
    title
    Arm II (Vinorelbine, Cisplatin)
  3. description
    Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II. Cisplatin: Given IV Gemcitabine Hydrochloride Quality-of-Life Assessment: Ancillary studies
    id
    OG002
    title
    Arm III (Gemcitabine, Cisplatin)
  4. description
    Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Topotecan Hydrochloride: Given IV
    id
    OG003
    title
    Arm IV (Topotecan, Cisplatin)
param Type
MEAN
population Description
Patients who provided baseline and ≥ one follow-up assessments
reporting Status
POSTED
time Frame
Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1
title
Pain, Assessed by Brief Pain Inventory
type
SECONDARY
unit Of Measure
units on a scale

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice