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NCT02094261 · FLOW

Participant flow

Phase II AZD9291 Open Label Study in NSCLC After Previous EGFR TKI Therapy in EGFR and T790M Mutation Positive Tumours · Source last updated 2024-11-06

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

groups
  1. description
    Daily single dose of AZD9291 80mg
    id
    FG000
    title
    AZD9291 80mg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        24
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        181
      type
      Ongoing Study at Data Cut-off
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        210
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        210
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
472 patients were enrolled (signed informed consent). Patients were assigned to treatment if they met all the inclusion and none of the exclusion criteria. 262 patients were enrolled but failed inclusion/exclusion criteria and so were not eligible to be assigned treatment. The remaining 210 patients received treatment.
recruitment Details
First patient enrolled: 28 April 2014, Data cut off: 1 May 2015. The study was open for enrolment at 44 study centres in Canada (3), Hong Kong (2), Italy (5), Japan (14), South Korea (3), Spain (6), Taiwan (2), and the USA (9). Recruitment has closed and primary analyses have been performed but study is still on-going.
Complete source fields
groups
  1. description
    Daily single dose of AZD9291 80mg
    id
    FG000
    title
    AZD9291 80mg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        24
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        181
      type
      Ongoing Study at Data Cut-off
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        210
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        210
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
472 patients were enrolled (signed informed consent). Patients were assigned to treatment if they met all the inclusion and none of the exclusion criteria. 262 patients were enrolled but failed inclusion/exclusion criteria and so were not eligible to be assigned treatment. The remaining 210 patients received treatment.
recruitment Details
First patient enrolled: 28 April 2014, Data cut off: 1 May 2015. The study was open for enrolment at 44 study centres in Canada (3), Hong Kong (2), Italy (5), Japan (14), South Korea (3), Spain (6), Taiwan (2), and the USA (9). Recruitment has closed and primary analyses have been performed but study is still on-going.

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

Preserved source evidence · Not medical advice