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NCT02793128 · OUTCOME

Durability of Complete Response (CR) for Each Follow-up Time Point.

The OLYMPUS Study - Optimized DeLivery of Mitomycin for Primary UTUC Study · Source last updated 2020-12-22

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
3, 6, 9 and 12 months

What was measured

Durability of CR defined dichotomously as "Success" if CR was achieved at Primary Disease Evaluation (PDE) visit and remained at follow-up Visit 1, Visit 2 and Visit 3 (3, 6, 9 and 12 months post PDE visit), and "Failure" otherwise.

Groups in this outcome

UGN-101 Patients Evaluated 3 Months Post PDE

Patients reaching CR at PDE evaluated at 3 months post PDE

UGN-101 Patients Evaluated at 6 Months Post PDE

Patients reaching CR at PDE evaluated at 6 months post PDE

UGN-101 Patients Evaluated at 9 Months Post PDE

Patients reaching CR at PDE evaluated at 9 months post PDE

UGN-101 Patients Evaluated at 12 Months Post PDE

Patients reaching CR at PDE evaluated at 12 months post PDE

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

Analysis denominator · Participants

GroupSource count
UGN-101 Patients Evaluated 3 Months Post PDE38
UGN-101 Patients Evaluated at 6 Months Post PDE38
UGN-101 Patients Evaluated at 9 Months Post PDE35
UGN-101 Patients Evaluated at 12 Months Post PDE31

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
UGN-101 Patients Evaluated 3 Months Post PDE35Not reportedNot reportedNot reportedNot reported
UGN-101 Patients Evaluated at 6 Months Post PDE33Not reportedNot reportedNot reportedNot reported
UGN-101 Patients Evaluated at 9 Months Post PDE28Not reportedNot reportedNot reportedNot reported
UGN-101 Patients Evaluated at 12 Months Post PDE23Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        35
      2. group Id
        OG001
        value
        33
      3. group Id
        OG002
        value
        28
      4. group Id
        OG003
        value
        23
denoms
  1. counts
    1. group Id
      OG000
      value
      38
    2. group Id
      OG001
      value
      38
    3. group Id
      OG002
      value
      35
    4. group Id
      OG003
      value
      31
    units
    Participants
description
Durability of CR defined dichotomously as "Success" if CR was achieved at Primary Disease Evaluation (PDE) visit and remained at follow-up Visit 1, Visit 2 and Visit 3 (3, 6, 9 and 12 months post PDE visit), and "Failure" otherwise.
groups
  1. description
    Patients reaching CR at PDE evaluated at 3 months post PDE
    id
    OG000
    title
    UGN-101 Patients Evaluated 3 Months Post PDE
  2. description
    Patients reaching CR at PDE evaluated at 6 months post PDE
    id
    OG001
    title
    UGN-101 Patients Evaluated at 6 Months Post PDE
  3. description
    Patients reaching CR at PDE evaluated at 9 months post PDE
    id
    OG002
    title
    UGN-101 Patients Evaluated at 9 Months Post PDE
  4. description
    Patients reaching CR at PDE evaluated at 12 months post PDE
    id
    OG003
    title
    UGN-101 Patients Evaluated at 12 Months Post PDE
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
3, 6, 9 and 12 months
title
Durability of Complete Response (CR) for Each Follow-up Time Point.
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice