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NCT01140347 · FLOW

Participant flow

A Study of Ramucirumab (IMC-1121B) Drug Product (DP) and Best Supportive Care (BSC) Versus Placebo and BSC as 2nd-Line Treatment in Participants With Hepatocellular Carcinoma After 1st-Line Therapy With Sorafenib · Source last updated 2015-12-28

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

groups
  1. description
    Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) intravenous (IV) infusion every 2 weeks. Best supportive care (BSC): Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
    id
    FG000
    title
    Ramucirumab (IMC-1121B) + BSC
  2. description
    Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
    id
    FG001
    title
    Placebo + BSC
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        6
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        8
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        283
      2. group Id
        FG001
        num Subjects
        282
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        277
      2. group Id
        FG001
        num Subjects
        276
      type
      Received at Least 1 Dose of Study Drug
    3. achievements
      1. group Id
        FG000
        num Subjects
        265
      2. group Id
        FG001
        num Subjects
        268
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        18
      2. group Id
        FG001
        num Subjects
        14
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants who died due to any cause or were alive and on study at conclusion but off treatment were considered to have completed the study.
Complete source fields
groups
  1. description
    Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) intravenous (IV) infusion every 2 weeks. Best supportive care (BSC): Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
    id
    FG000
    title
    Ramucirumab (IMC-1121B) + BSC
  2. description
    Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
    id
    FG001
    title
    Placebo + BSC
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        6
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        8
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        283
      2. group Id
        FG001
        num Subjects
        282
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        277
      2. group Id
        FG001
        num Subjects
        276
      type
      Received at Least 1 Dose of Study Drug
    3. achievements
      1. group Id
        FG000
        num Subjects
        265
      2. group Id
        FG001
        num Subjects
        268
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        18
      2. group Id
        FG001
        num Subjects
        14
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants who died due to any cause or were alive and on study at conclusion but off treatment were considered to have completed the study.

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

Preserved source evidence · Not medical advice