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NCT00565851 · OUTCOME

Summary of Adverse Events (CTCAE Version 4.0)

Carboplatin, Paclitaxel and Gemcitabine Hydrochloride With or Without Bevacizumab After Surgery in Treating Patients With Recurrent Ovarian, Epithelial, Primary Peritoneal, or Fallopian Tube Cancer · Source last updated 2025-12-30

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
During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months

What was measured

Number of treated patients with at least one adverse event reported (assessed by Common Terminology Criteria for Adverse Events (version 4.0))

Analysis population: Eligible and treated participants

Groups in this outcome

Arm I (no Surgery; Carboplatin and Paclitaxel)

Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients are not in secondary cytoreductive surgery portion of study. Carboplatin: Given IV Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies

Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab)

Patients receive chemotherapy as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days. Patients are not in secondary cytoreductive surgery portion of study. Bevacizumab: Given IV Carboplatin: Given IV Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies

Arm III (Surgery; Carboplatin and Paclitaxel)

Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery. Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies

Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab)

Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery. Bevacizumab: Given IV Carboplatin: Given IV Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies

Arm V (no Surgery; Carboplatin and Gemcitabine)

Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery. Carboplatin: Given IV Gemcitabine Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies

Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab))

Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery. Bevacizumab: Given IV Carboplatin: Given IV Gemcitabine Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies

Arm VII (Surgery; Carboplatin and Gemcitabine)

Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery. Carboplatin: Given IV Gemcitabine Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies

Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab))

Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery. Bevacizumab: Given IV Carboplatin: Given IV Gemcitabine Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies

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 (no Surgery; Carboplatin and Paclitaxel)316
Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab)456
Arm III (Surgery; Carboplatin and Paclitaxel)33
Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab)165
Arm V (no Surgery; Carboplatin and Gemcitabine)6
Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab))34
Arm VII (Surgery; Carboplatin and Gemcitabine)5
Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab))37

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (no Surgery; Carboplatin and Paclitaxel)304Not reportedNot reportedNot reportedNot reported
Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab)376Not reportedNot reportedNot reportedNot reported
Arm III (Surgery; Carboplatin and Paclitaxel)29Not reportedNot reportedNot reportedNot reported
Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab)77Not reportedNot reportedNot reportedNot reported
Arm V (no Surgery; Carboplatin and Gemcitabine)3Not reportedNot reportedNot reportedNot reported
Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab))9Not reportedNot reportedNot reportedNot reported
Arm VII (Surgery; Carboplatin and Gemcitabine)3Not reportedNot reportedNot reportedNot reported
Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab))9Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        304
      2. group Id
        OG001
        value
        376
      3. group Id
        OG002
        value
        29
      4. group Id
        OG003
        value
        77
      5. group Id
        OG004
        value
        3
      6. group Id
        OG005
        value
        9
      7. group Id
        OG006
        value
        3
      8. group Id
        OG007
        value
        9
denoms
  1. counts
    1. group Id
      OG000
      value
      316
    2. group Id
      OG001
      value
      456
    3. group Id
      OG002
      value
      33
    4. group Id
      OG003
      value
      165
    5. group Id
      OG004
      value
      6
    6. group Id
      OG005
      value
      34
    7. group Id
      OG006
      value
      5
    8. group Id
      OG007
      value
      37
    units
    Participants
description
Number of treated patients with at least one adverse event reported (assessed by Common Terminology Criteria for Adverse Events (version 4.0))
groups
  1. description
    Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients are not in secondary cytoreductive surgery portion of study. Carboplatin: Given IV Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies
    id
    OG000
    title
    Arm I (no Surgery; Carboplatin and Paclitaxel)
  2. description
    Patients receive chemotherapy as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days. Patients are not in secondary cytoreductive surgery portion of study. Bevacizumab: Given IV Carboplatin: Given IV Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies
    id
    OG001
    title
    Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab)
  3. description
    Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery. Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies
    id
    OG002
    title
    Arm III (Surgery; Carboplatin and Paclitaxel)
  4. description
    Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery. Bevacizumab: Given IV Carboplatin: Given IV Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies
    id
    OG003
    title
    Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab)
  5. description
    Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery. Carboplatin: Given IV Gemcitabine Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies
    id
    OG004
    title
    Arm V (no Surgery; Carboplatin and Gemcitabine)
  6. description
    Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery. Bevacizumab: Given IV Carboplatin: Given IV Gemcitabine Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies
    id
    OG005
    title
    Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab))
  7. description
    Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery. Carboplatin: Given IV Gemcitabine Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies
    id
    OG006
    title
    Arm VII (Surgery; Carboplatin and Gemcitabine)
  8. description
    Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery. Bevacizumab: Given IV Carboplatin: Given IV Gemcitabine Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies
    id
    OG007
    title
    Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab))
param Type
COUNT_OF_PARTICIPANTS
population Description
Eligible and treated participants
reporting Status
POSTED
time Frame
During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months
title
Summary of Adverse Events (CTCAE Version 4.0)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice