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NCT00262847 · OUTCOME

Overall Survival

Carboplatin and Paclitaxel With or Without Bevacizumab in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer · Source last updated 2019-07-23

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From study entry to death or last contact, up to 6 years

What was measured

Median overall survival (OS)

Groups in this outcome

Arm I (Placebo, Paclitaxel, Carboplatin)

Control therapy: Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks. Cycles 7-22 received placebo every 3 weeks.

Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)

Bevacizumab-initiation therapy: Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks. Cycles 7-22 received placebo every 3 weeks.

Arm III (Paclitaxel, Carboplatin, Bevacizumab)

Bevacizumab-throughout therapy: Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks. Cycles 7-22 received bevacizumab, 15 mg/kg every 3 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 I (Placebo, Paclitaxel, Carboplatin)625
Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)625
Arm III (Paclitaxel, Carboplatin, Bevacizumab)623

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Placebo, Paclitaxel, Carboplatin)40.6Not reported37.145.5Not reported
Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)38.7Not reported35.242.1Not reported
Arm III (Paclitaxel, Carboplatin, Bevacizumab)43.8Not reported39.749.0Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.912
    ci Pct Value
    95
    ci Upper Limit
    1.255
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.410
    param Type
    Hazard Ratio (HR)
    param Value
    1.069
    statistical Comment
    Proportional Hazards model stratified by stage of disease and size of residual disease following initial staging surgery.
    statistical Method
    Regression, Cox
  2. ci Lower Limit
    0.746
    ci Pct Value
    95
    ci Upper Limit
    1.039
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.131
    param Type
    Hazard Ratio (HR)
    param Value
    0.880
    statistical Comment
    Proportional Hazards model stratified by stage of disease and size of residual disease following initial staging surgery.
    statistical Method
    Regression, Cox
Complete source fields
analyses
  1. ci Lower Limit
    0.912
    ci Pct Value
    95
    ci Upper Limit
    1.255
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.410
    param Type
    Hazard Ratio (HR)
    param Value
    1.069
    statistical Comment
    Proportional Hazards model stratified by stage of disease and size of residual disease following initial staging surgery.
    statistical Method
    Regression, Cox
  2. ci Lower Limit
    0.746
    ci Pct Value
    95
    ci Upper Limit
    1.039
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.131
    param Type
    Hazard Ratio (HR)
    param Value
    0.880
    statistical Comment
    Proportional Hazards model stratified by stage of disease and size of residual disease following initial staging surgery.
    statistical Method
    Regression, Cox
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        37.1
        upper Limit
        45.5
        value
        40.6
      2. group Id
        OG001
        lower Limit
        35.2
        upper Limit
        42.1
        value
        38.7
      3. group Id
        OG002
        lower Limit
        39.7
        upper Limit
        49.0
        value
        43.8
denoms
  1. counts
    1. group Id
      OG000
      value
      625
    2. group Id
      OG001
      value
      625
    3. group Id
      OG002
      value
      623
    units
    Participants
description
Median overall survival (OS)
dispersion Type
95% Confidence Interval
groups
  1. description
    Control therapy: Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks. Cycles 7-22 received placebo every 3 weeks.
    id
    OG000
    title
    Arm I (Placebo, Paclitaxel, Carboplatin)
  2. description
    Bevacizumab-initiation therapy: Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks. Cycles 7-22 received placebo every 3 weeks.
    id
    OG001
    title
    Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)
  3. description
    Bevacizumab-throughout therapy: Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks. Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks.
    id
    OG002
    title
    Arm III (Paclitaxel, Carboplatin, Bevacizumab)
param Type
MEDIAN
reporting Status
POSTED
time Frame
From study entry to death or last contact, up to 6 years
title
Overall Survival
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice