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NCT00109928 · OUTCOME

Response Rate

S0350 Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Peripheral T-Cell Non-Hodgkin's Lymphoma · Source last updated 2014-10-01

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
up to 3 years or time of disease progression

What was measured

Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.

Analysis population: All eligible patients who started protocol treatment were included in the analysis.

Groups in this outcome

PEGS

Patients received IV cisplatin 25 mg/m2 days 1-4, etoposide 40 mg/m2 days 1-4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1-4 of a 21 day cycle for 6 cycles.

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

Analysis denominator · Participants

GroupSource count
PEGS33

Reported measurements

Complete Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGS6Not reportedNot reportedNot reportedNot reported
Unconfirmed Complete Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGS2Not reportedNot reportedNot reportedNot reported
Partial Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGS5Not reportedNot reportedNot reportedNot reported
No Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PEGS20Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    Complete Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Unconfirmed Complete Response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    Partial Response
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        20
    title
    No Response
denoms
  1. counts
    1. group Id
      OG000
      value
      33
    units
    Participants
description
Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.
groups
  1. description
    Patients received IV cisplatin 25 mg/m2 days 1-4, etoposide 40 mg/m2 days 1-4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1-4 of a 21 day cycle for 6 cycles.
    id
    OG000
    title
    PEGS
param Type
NUMBER
population Description
All eligible patients who started protocol treatment were included in the analysis.
time Frame
up to 3 years or time of disease progression
title
Response Rate
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice