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NCT01595061 · OUTCOME

Adverse Events (Grade 3 or Higher) During Treatment Period

Radiation Therapy, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Locally Advanced Squamous Cell Cancer of the Vulva · Source last updated 2021-12-29

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 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.

What was measured

Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0.

Analysis population: Eligible and Treated

Groups in this outcome

GEM+CIS+IMRT

Gemcitabine 50 mg/m2 and Cisplatin 40mg/m2 administered weekly throughout IMRT radiation therapy. Gemcitabine will be infused prior to cisplatin and given over approximately 30 minutes while the cisplatin will be delivered over approximately 60 minutes.

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

Analysis denominator · Participants

GroupSource count
GEM+CIS+IMRT53

Reported measurements

Leukopenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GEM+CIS+IMRT27Not reportedNot reportedNot reportedNot reported
Thrombocytopenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GEM+CIS+IMRT20Not reportedNot reportedNot reportedNot reported
Neutropenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GEM+CIS+IMRT20Not reportedNot reportedNot reportedNot reported
Anemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GEM+CIS+IMRT20Not reportedNot reportedNot reportedNot reported
Other Investigations
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GEM+CIS+IMRT7Not reportedNot reportedNot reportedNot reported
Other blood and lymphatic disorders
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GEM+CIS+IMRT8Not reportedNot reportedNot reportedNot reported
Cardiac disorders
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GEM+CIS+IMRT2Not reportedNot reportedNot reportedNot reported
Gastrointestinal disorders
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GEM+CIS+IMRT10Not reportedNot reportedNot reportedNot reported
General disorders and administration site conditions
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GEM+CIS+IMRT5Not reportedNot reportedNot reportedNot reported
Infections and infestations
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GEM+CIS+IMRT5Not reportedNot reportedNot reportedNot reported
Injury, poisoning and procedural complications
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GEM+CIS+IMRT20Not reportedNot reportedNot reportedNot reported
Metabolism and nutrition disorders
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GEM+CIS+IMRT19Not reportedNot reportedNot reportedNot reported
Musculoskeletal and connective tissue disorders
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GEM+CIS+IMRT2Not reportedNot reportedNot reportedNot reported
Peripheral sensory neuropathy
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GEM+CIS+IMRT1Not reportedNot reportedNot reportedNot reported
Other nervous system disorders
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GEM+CIS+IMRT2Not reportedNot reportedNot reportedNot reported
Renal and urinary disorders
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GEM+CIS+IMRT1Not reportedNot reportedNot reportedNot reported
Reproductive system and breast disorders
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GEM+CIS+IMRT7Not reportedNot reportedNot reportedNot reported
Respiratory, thoracic and mediastinal disorders
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GEM+CIS+IMRT1Not reportedNot reportedNot reportedNot reported
Skin and subcutaneous tissue disorders
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GEM+CIS+IMRT4Not reportedNot reportedNot reportedNot reported
Surgical and medical procedures
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GEM+CIS+IMRT1Not reportedNot reportedNot reportedNot reported
Vascular disorders
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GEM+CIS+IMRT5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        27
    title
    Leukopenia
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        20
    title
    Thrombocytopenia
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        20
    title
    Neutropenia
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        20
    title
    Anemia
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        7
    title
    Other Investigations
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    Other blood and lymphatic disorders
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Cardiac disorders
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        10
    title
    Gastrointestinal disorders
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    General disorders and administration site conditions
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    Infections and infestations
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        20
    title
    Injury, poisoning and procedural complications
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        19
    title
    Metabolism and nutrition disorders
denoms
  1. counts
    1. group Id
      OG000
      value
      53
    units
    Participants
description
Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0.
groups
  1. description
    Gemcitabine 50 mg/m2 and Cisplatin 40mg/m2 administered weekly throughout IMRT radiation therapy. Gemcitabine will be infused prior to cisplatin and given over approximately 30 minutes while the cisplatin will be delivered over approximately 60 minutes.
    id
    OG000
    title
    GEM+CIS+IMRT
param Type
COUNT_OF_PARTICIPANTS
population Description
Eligible and Treated
reporting Status
POSTED
time Frame
During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
title
Adverse Events (Grade 3 or Higher) During Treatment Period
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice