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NCT01457417 · OUTCOME

Overall Survival (OS) in Patients With Relapsed or Refractory NSCLC

A Study of DKN-01 in Multiple Myeloma or Advanced Solid Tumors · Source last updated 2016-09-28

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

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Time from the date of signed informed consent to the date of death from any cause

What was measured

For Part B only. OS was defined as the time from the date of signed informed consent to the date of death from any cause. For patients who were still alive as of the data cut-off date, OS time was censored on the date of the patient's last contact (last contact for patients in post-discontinuation was the last date of contact in long-term follow-up eCRF).

Analysis population: For patients who are still alive as of the data cut-off date, OS time will be censored on the date of the patient's last contact (last contact for patients in post-discontinuation = last Date of Contact in Long Term Follow-up eCRF).

Groups in this outcome

300 mg DKN-01 Part B (Q2W)

Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.

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

Analysis denominator · Participants

GroupSource count
300 mg DKN-01 Part B (Q2W)19

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
300 mg DKN-01 Part B (Q2W)6.6Not reported4.110.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.1
        upper Limit
        10.1
        value
        6.6
denoms
  1. counts
    1. group Id
      OG000
      value
      19
    units
    Participants
description
For Part B only. OS was defined as the time from the date of signed informed consent to the date of death from any cause. For patients who were still alive as of the data cut-off date, OS time was censored on the date of the patient's last contact (last contact for patients in post-discontinuation was the last date of contact in long-term follow-up eCRF).
dispersion Type
95% Confidence Interval
groups
  1. description
    Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
    id
    OG000
    title
    300 mg DKN-01 Part B (Q2W)
param Type
MEDIAN
population Description
For patients who are still alive as of the data cut-off date, OS time will be censored on the date of the patient's last contact (last contact for patients in post-discontinuation = last Date of Contact in Long Term Follow-up eCRF).
reporting Status
POSTED
time Frame
Time from the date of signed informed consent to the date of death from any cause
title
Overall Survival (OS) in Patients With Relapsed or Refractory NSCLC
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice