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NCT01761266 · FLOW

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A Multicenter, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib (E7080) Versus Sorafenib in First-line Treatment of Participants With Unresectable Hepatocellular Carcinoma · Source last updated 2022-04-05

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

groups
  1. description
    Participants received lenvatinib capsules 12 milligram (mg) based on the participant's body weight greater than or equal to (\>=) 60 kilogram (kg) or 8 mg based on the participant's body weight less than (\<) 60 kg at baseline, orally, once daily (QD) in continuous 28-day treatment cycles up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
    id
    FG000
    title
    Lenvatinib
  2. description
    Participants received sorafenib 400 mg tablets, orally, twice daily (BID) in continuous 28-day treatment cycles up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
    id
    FG001
    title
    Sorafenib
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        415
      2. group Id
        FG001
        num Subjects
        402
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        12
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        10
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        41
      2. group Id
        FG001
        num Subjects
        52
      type
      Sponsor Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        478
      2. group Id
        FG001
        num Subjects
        476
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        476
      2. group Id
        FG001
        num Subjects
        475
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        478
      2. group Id
        FG001
        num Subjects
        476
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A total of 1,492 participants were screened, 954 participants were enrolled and randomized, out of which 951 participants were treated in the study.
recruitment Details
Participants took part in the study at 154 investigative sites in Australia, Belgium, Canada, China, France, Germany, Hong Kong, Israel, Italy, Japan, South Korea, Malaysia, Philippines, Poland, Russia, Singapore, Spain, Taiwan, Thailand, United Kingdom, and the United States from 1 March 2013 to 10 March 2021.
Complete source fields
groups
  1. description
    Participants received lenvatinib capsules 12 milligram (mg) based on the participant's body weight greater than or equal to (\>=) 60 kilogram (kg) or 8 mg based on the participant's body weight less than (\<) 60 kg at baseline, orally, once daily (QD) in continuous 28-day treatment cycles up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
    id
    FG000
    title
    Lenvatinib
  2. description
    Participants received sorafenib 400 mg tablets, orally, twice daily (BID) in continuous 28-day treatment cycles up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
    id
    FG001
    title
    Sorafenib
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        415
      2. group Id
        FG001
        num Subjects
        402
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        12
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        10
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        41
      2. group Id
        FG001
        num Subjects
        52
      type
      Sponsor Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        478
      2. group Id
        FG001
        num Subjects
        476
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        476
      2. group Id
        FG001
        num Subjects
        475
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        478
      2. group Id
        FG001
        num Subjects
        476
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A total of 1,492 participants were screened, 954 participants were enrolled and randomized, out of which 951 participants were treated in the study.
recruitment Details
Participants took part in the study at 154 investigative sites in Australia, Belgium, Canada, China, France, Germany, Hong Kong, Israel, Italy, Japan, South Korea, Malaysia, Philippines, Poland, Russia, Singapore, Spain, Taiwan, Thailand, United Kingdom, and the United States from 1 March 2013 to 10 March 2021.

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

Preserved source evidence · Not medical advice