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NCT02365597 · OUTCOME

Main Study: Overall Survival

An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer · Source last updated 2026-08-28

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

Measure
MEDIAN
Unit
months
Interval / dispersion
Full Range
Time frame
From screening up to 6 years 2 months

What was measured

Overall survival is defined as the time from the date of first dose of study drug to the date of the participant's death from any cause.

Analysis population: The population included participants who received at least 1 dose of study drug.

Groups in this outcome

Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg

Participants received single dose of erdafitinib 10 mg tablet, orally, once daily, starting from Day 1 through Day 7 and from Day 15 through Day 21 and so on, that is 7-day on and off in each subsequent 28-day cycles starting from Cycle 1. Based on serum phosphate (PO4) levels, there was an option to up-titrate erdafitinib dose to 12 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.

Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg

Participants received single dose of erdafitinib 6 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 8 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.

Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg

Participants received single dose of erdafitinib 8 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 9 mg, orally, once daily starting from Cycle 1 Day 15 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.

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

Analysis denominator · Participants

GroupSource count
Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg33
Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg78
Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg101

Reported measurements

Source class 1
Values in months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg7.46Not reported1.764.0Not reported
Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg8.64Not reported0.460.1Not reported
Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg11.30Not reported0.756.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.7
        upper Limit
        64.0
        value
        7.46
      2. group Id
        OG001
        lower Limit
        0.4
        upper Limit
        60.1
        value
        8.64
      3. group Id
        OG002
        lower Limit
        0.7
        upper Limit
        56.9
        value
        11.30
denoms
  1. counts
    1. group Id
      OG000
      value
      33
    2. group Id
      OG001
      value
      78
    3. group Id
      OG002
      value
      101
    units
    Participants
description
Overall survival is defined as the time from the date of first dose of study drug to the date of the participant's death from any cause.
dispersion Type
Full Range
groups
  1. description
    Participants received single dose of erdafitinib 10 mg tablet, orally, once daily, starting from Day 1 through Day 7 and from Day 15 through Day 21 and so on, that is 7-day on and off in each subsequent 28-day cycles starting from Cycle 1. Based on serum phosphate (PO4) levels, there was an option to up-titrate erdafitinib dose to 12 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.
    id
    OG000
    title
    Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg
  2. description
    Participants received single dose of erdafitinib 6 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 8 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.
    id
    OG001
    title
    Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg
  3. description
    Participants received single dose of erdafitinib 8 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 9 mg, orally, once daily starting from Cycle 1 Day 15 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.
    id
    OG002
    title
    Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg
param Type
MEDIAN
population Description
The population included participants who received at least 1 dose of study drug.
reporting Status
POSTED
time Frame
From screening up to 6 years 2 months
title
Main Study: Overall Survival
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice