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NCT02773849 · FLOW

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ADSTILADRIN (=INSTILADRIN) in Patients With High-Grade, Bacillus Calmette-Guerin (BCG) Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) · Source last updated 2024-07-29

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

groups
  1. description
    Intravesical administration of ADSTILADRIN into the bladder
    id
    FG000
    title
    ADSTILADRIN
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        11
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        26
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        5
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        9
      type
      Withdrawal of Consent
    5. reasons
      1. group Id
        FG000
        num Subjects
        11
      type
      Other: not due to lack of tolerability
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        157
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        95
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        62
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
Patients enrolled in the study who had at entry, confirmed by a pathology report: CIS only or Ta/T1 high- grade disease with concomitant CIS, or Ta/T1 high-grade disease without concomitant CIS and were "BCG unresponsive" which referred to patients with high-grade NMIBC who were unlikely to benefit from and who did not receive further intravesical BCG.
Complete source fields
groups
  1. description
    Intravesical administration of ADSTILADRIN into the bladder
    id
    FG000
    title
    ADSTILADRIN
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        11
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        26
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        5
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        9
      type
      Withdrawal of Consent
    5. reasons
      1. group Id
        FG000
        num Subjects
        11
      type
      Other: not due to lack of tolerability
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        157
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        95
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        62
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
Patients enrolled in the study who had at entry, confirmed by a pathology report: CIS only or Ta/T1 high- grade disease with concomitant CIS, or Ta/T1 high-grade disease without concomitant CIS and were "BCG unresponsive" which referred to patients with high-grade NMIBC who were unlikely to benefit from and who did not receive further intravesical BCG.

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

Preserved source evidence · Not medical advice