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NCT00101413 · OUTCOME

Duration of Stable Disease

BAY43-9006 - Phase II Study in Non-Small Cell Lung Carcinoma (NSCLC) · Source last updated 2013-10-30

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

Measure
MEDIAN
Unit
days
Interval / dispersion
95% Confidence Interval
Time frame
First patient first treatment until date for last data collection for efficacy for a study period up to 62 weeks. Tumor assessed per RECIST at baseline (BL), every 8 weeks during treatment and at end of treatment.

What was measured

Duration of stable disease was calculated as date of first treatment until date of documented progressive disease (PD) or last observation if subject did not progress. Stable disease (SD) defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Kaplan-Meier methodology, descriptive analysis.

Analysis population: The analysis population for the intent to treat (ITT) and safety analyses consisted of 52 subjects who received at least 1 treatment and had their disease re-evaluated. 1 of the 52 subjects had lung metastases from pancreatic cancer and was excluded from analysis. 48 subjects had tumor evaluations post-baseline and were evaluable.

Groups in this outcome

Sorafenib

Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day 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
Sorafenib48

Reported measurements

Source class 1
Values in days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Sorafenib103Not reported58116Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        58
        upper Limit
        116
        value
        103
denoms
  1. counts
    1. group Id
      OG000
      value
      48
    units
    Participants
description
Duration of stable disease was calculated as date of first treatment until date of documented progressive disease (PD) or last observation if subject did not progress. Stable disease (SD) defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Kaplan-Meier methodology, descriptive analysis.
dispersion Type
95% Confidence Interval
groups
  1. description
    Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
    id
    OG000
    title
    Sorafenib
param Type
MEDIAN
population Description
The analysis population for the intent to treat (ITT) and safety analyses consisted of 52 subjects who received at least 1 treatment and had their disease re-evaluated. 1 of the 52 subjects had lung metastases from pancreatic cancer and was excluded from analysis. 48 subjects had tumor evaluations post-baseline and were evaluable.
reporting Status
POSTED
time Frame
First patient first treatment until date for last data collection for efficacy for a study period up to 62 weeks. Tumor assessed per RECIST at baseline (BL), every 8 weeks during treatment and at end of treatment.
title
Duration of Stable Disease
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice