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NCT01170663 · FLOW

Participant flow

A Study of Paclitaxel With or Without Ramucirumab (IMC-1211B) in Metastatic Gastric Adenocarcinoma · Source last updated 2019-09-18

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

groups
  1. description
    8 milligrams/kilogram (mg/kg) of ramucirumab (IMC-1121B) was administered by intravenous (IV) infusion on Days 1 and 15 in combination with 80 milligrams/square meter (mg/m²) paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
    id
    FG000
    title
    Ramucirumab (IMC-1211B) Plus Paclitaxel
  2. description
    Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
    id
    FG001
    title
    Placebo Plus Paclitaxel
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        9
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        11
      type
      Withdrawal of consent without follow-up
    milestones
    1. achievements
      1. comment
        Participant was included in ramucirumab (IMC-1121B)/paclitaxel treatment arm (safety population).
        group Id
        FG000
        num Subjects
        330
      2. comment
        Participant was included in the placebo/paclitaxel treatment arm (intent-to-treat (ITT) population).
        group Id
        FG001
        num Subjects
        335
      comment
      One participant randomized to placebo/paclitaxel arm but received ramucirumab (IMC-1121B) in error.
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        327
      2. group Id
        FG001
        num Subjects
        329
      type
      Received Any Treatment (Safety Pop)
    3. achievements
      1. group Id
        FG000
        num Subjects
        316
      2. group Id
        FG001
        num Subjects
        315
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        20
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Completers include participants that discontinued study drugs either due to progressive disease (PD), due to an adverse event or died due to any cause, but not necessarily had any survival-FU assessment done.
Complete source fields
groups
  1. description
    8 milligrams/kilogram (mg/kg) of ramucirumab (IMC-1121B) was administered by intravenous (IV) infusion on Days 1 and 15 in combination with 80 milligrams/square meter (mg/m²) paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
    id
    FG000
    title
    Ramucirumab (IMC-1211B) Plus Paclitaxel
  2. description
    Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
    id
    FG001
    title
    Placebo Plus Paclitaxel
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        9
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        11
      type
      Withdrawal of consent without follow-up
    milestones
    1. achievements
      1. comment
        Participant was included in ramucirumab (IMC-1121B)/paclitaxel treatment arm (safety population).
        group Id
        FG000
        num Subjects
        330
      2. comment
        Participant was included in the placebo/paclitaxel treatment arm (intent-to-treat (ITT) population).
        group Id
        FG001
        num Subjects
        335
      comment
      One participant randomized to placebo/paclitaxel arm but received ramucirumab (IMC-1121B) in error.
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        327
      2. group Id
        FG001
        num Subjects
        329
      type
      Received Any Treatment (Safety Pop)
    3. achievements
      1. group Id
        FG000
        num Subjects
        316
      2. group Id
        FG001
        num Subjects
        315
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        20
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Completers include participants that discontinued study drugs either due to progressive disease (PD), due to an adverse event or died due to any cause, but not necessarily had any survival-FU assessment done.

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

Preserved source evidence · Not medical advice