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NCT00661609 · FLOW

Participant flow

A Phase II Study of AZD4877 (a Novel Anti-mitotic Agent) in Advanced Bladder Cancer · Source last updated 2011-01-12

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

groups
  1. description
    AZD4877 25 mg (Intravenous (IV), 25mg weekly)
    id
    FG000
    title
    AZD4877
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        20
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      PI Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        11
      type
      Survival follow up stage discontinued
    6. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Disease progression
    milestones
    1. achievements
      1. comment
        All dosed patients
        group Id
        FG000
        num Subjects
        41
      type
      STARTED
    2. achievements
      1. comment
        Treatment is not for a fixed period and continues until a discontinuation criterion is met.
        group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        41
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Following enrolment there was a screening period of up to 28 days, after which if all inclusion/exclusion criteria were met, patients were dosed with AZD4877.
recruitment Details
Patients were recruited at 23 study sites in 5 countries: United States (7 centers), United Kingdom (6 centers), Germany (5 centers), Canada (3 centers), and Spain (2 centers) between 29 May 2008 and 11 January 2010. 54 participants were enrolled into the study of which 41 participants received at least one dose of study medication.
Complete source fields
groups
  1. description
    AZD4877 25 mg (Intravenous (IV), 25mg weekly)
    id
    FG000
    title
    AZD4877
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        20
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      PI Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        11
      type
      Survival follow up stage discontinued
    6. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Disease progression
    milestones
    1. achievements
      1. comment
        All dosed patients
        group Id
        FG000
        num Subjects
        41
      type
      STARTED
    2. achievements
      1. comment
        Treatment is not for a fixed period and continues until a discontinuation criterion is met.
        group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        41
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Following enrolment there was a screening period of up to 28 days, after which if all inclusion/exclusion criteria were met, patients were dosed with AZD4877.
recruitment Details
Patients were recruited at 23 study sites in 5 countries: United States (7 centers), United Kingdom (6 centers), Germany (5 centers), Canada (3 centers), and Spain (2 centers) between 29 May 2008 and 11 January 2010. 54 participants were enrolled into the study of which 41 participants received at least one dose of study medication.

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Preserved source evidence · Not medical advice