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NCT00101413 · OUTCOME

Percentage of Subjects With Stable Disease (SD)

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
NUMBER
Unit
Percentage of participants
Interval / dispersion
Not reported
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

Percentage of subjects with stable disease was calculated from 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. Descriptive summary of subjects with SD.

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. 51 subjects were considered evaluable since 1 of the 52 subjects had lung metastases from pancreatic cancer.

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
Sorafenib51

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sorafenib58.8Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        58.8
denoms
  1. counts
    1. group Id
      OG000
      value
      51
    units
    Participants
description
Percentage of subjects with stable disease was calculated from 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. Descriptive summary of subjects with SD.
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
NUMBER
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. 51 subjects were considered evaluable since 1 of the 52 subjects had lung metastases from pancreatic cancer.
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
Percentage of Subjects With Stable Disease (SD)
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice