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NCT04803305 · FLOW

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Study to Compare the Effects of Repeated Doses of an Investigational New Drug and a Placebo on Appetite in Advanced Cancer and Anorexia · Source last updated 2024-01-12

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

groups
  1. description
    Participants received placebo during the 6-week double-blind phase (Part A) 3 weeks apart (Q3W) subcutaneously (SC). Starting at the Week 6 visit, participants who continued to the optional open-label treatment (OLT) period of up to 18 weeks (Part B) had an opportunity to receive up to 7 additional doses of PF-06946860 200 mg Q3W. Each dose was comprised of two 1 mL SC injections which were administered consecutively.
    id
    FG000
    title
    Placebo -> OL PF-06946860 200mg Q3W
  2. description
    Participants received PF-06946860 200 mg during the 6-week double-blind phase (Part A) Q3W SC. Starting at the Week 6 visit, participants who continued to the optional OLT period of up to 18 weeks (Part B) had an opportunity to receive up to 7 additional doses of PF-06946860 200 mg Q3W. Each dose was comprised of two 1 mL SC injections which were administered consecutively.
    id
    FG001
    title
    PF-06946860 200mg Q3W -> OL PF-06946860 200mg Q3W
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        12
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        9
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Part A: 6-week Double-blind Treatment
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Other
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Adverse Event
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        9
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        5
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        4
      type
      NOT COMPLETED
    title
    Part B: OLT Period up to 18 Weeks
pre Assignment Details
A total of 18 participants were enrolled into the study and treated.
Complete source fields
groups
  1. description
    Participants received placebo during the 6-week double-blind phase (Part A) 3 weeks apart (Q3W) subcutaneously (SC). Starting at the Week 6 visit, participants who continued to the optional open-label treatment (OLT) period of up to 18 weeks (Part B) had an opportunity to receive up to 7 additional doses of PF-06946860 200 mg Q3W. Each dose was comprised of two 1 mL SC injections which were administered consecutively.
    id
    FG000
    title
    Placebo -> OL PF-06946860 200mg Q3W
  2. description
    Participants received PF-06946860 200 mg during the 6-week double-blind phase (Part A) Q3W SC. Starting at the Week 6 visit, participants who continued to the optional OLT period of up to 18 weeks (Part B) had an opportunity to receive up to 7 additional doses of PF-06946860 200 mg Q3W. Each dose was comprised of two 1 mL SC injections which were administered consecutively.
    id
    FG001
    title
    PF-06946860 200mg Q3W -> OL PF-06946860 200mg Q3W
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        12
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        9
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Part A: 6-week Double-blind Treatment
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Other
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Adverse Event
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        9
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        5
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        4
      type
      NOT COMPLETED
    title
    Part B: OLT Period up to 18 Weeks
pre Assignment Details
A total of 18 participants were enrolled into the study and treated.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice