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NCT02300610 · OUTCOME

Overall Survival (OS)

Enzalutamide in Combination With Gemcitabine and Cisplatin in Bladder Cancer · Source last updated 2019-08-01

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
Up to 24 Months

What was measured

Dose Expansion. Overall survival is defined as the time from randomization until death from any cause, and is measured in the intent-to-treat population.

Groups in this outcome

Dose Escalation: Level 1 Dose

Dose Escalation: Level 1 dose of 80 mg enzalutamide (orally), with standard doses of cisplatin and gemcitabine via intravenous (IV).

Dose Escalation: Level 2 Dose

Dose Escalation: Level 2 dose of 160 mg enzalutamide (orally) with standard dose of cisplatin and gemcitabine via intravenous (IV).

Dose Expansion

Dose Expansion: Enzalutamide at MTD (160 mg) with standard doses of cisplatin and gemcitabine.

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

Analysis denominator · Participants

GroupSource count
Dose Escalation: Level 1 Dose3
Dose Escalation: Level 2 Dose3
Dose Expansion4

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dose Escalation: Level 1 Dose4.14Not reported3.8110.59Not reported
Dose Escalation: Level 2 Dose14.63Not reported13.7122.09Not reported
Dose Expansion10.03Not reported6.2520.05Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.81
        upper Limit
        10.59
        value
        4.14
      2. group Id
        OG001
        lower Limit
        13.71
        upper Limit
        22.09
        value
        14.63
      3. group Id
        OG002
        lower Limit
        6.25
        upper Limit
        20.05
        value
        10.03
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      4
    units
    Participants
description
Dose Expansion. Overall survival is defined as the time from randomization until death from any cause, and is measured in the intent-to-treat population.
dispersion Type
95% Confidence Interval
groups
  1. description
    Dose Escalation: Level 1 dose of 80 mg enzalutamide (orally), with standard doses of cisplatin and gemcitabine via intravenous (IV).
    id
    OG000
    title
    Dose Escalation: Level 1 Dose
  2. description
    Dose Escalation: Level 2 dose of 160 mg enzalutamide (orally) with standard dose of cisplatin and gemcitabine via intravenous (IV).
    id
    OG001
    title
    Dose Escalation: Level 2 Dose
  3. description
    Dose Expansion: Enzalutamide at MTD (160 mg) with standard doses of cisplatin and gemcitabine.
    id
    OG002
    title
    Dose Expansion
param Type
MEDIAN
reporting Status
POSTED
time Frame
Up to 24 Months
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice