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NCT00073307 · FLOW

Participant flow

Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer · Source last updated 2014-02-06

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

groups
  1. description
    Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily).
    id
    FG000
    title
    Sorafenib (Nexavar, BAY43-9006)
  2. description
    Subjects received matching placebo tablets administered orally twice a day. \[until \~31 May 2005\]
    id
    FG001
    title
    Placebo
  3. description
    Subjects received matching placebo tablets administered orally twice a day(as of \~31 May 2005) when after unblinding subjects switched over to receive Sorafenib orally administered as 2 x 200 mg tablets bid (twice daily).
    id
    FG002
    title
    Placebo Randomized, Switch to Sorafenib; Sorafenib Period Only
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        22
      2. group Id
        FG001
        num Subjects
        17
      3. group Id
        FG002
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        0
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        11
      3. group Id
        FG002
        num Subjects
        0
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Protocol Violation
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Non-compliant with Study medication
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Unknown reason.
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Protocol driven decision point
    8. reasons
      1. group Id
        FG000
        num Subjects
        165
      2. group Id
        FG001
        num Subjects
        114
      3. group Id
        FG002
        num Subjects
        0
      type
      entered Open Label (OL); Sorafenib only
    9. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Subject did not receive treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        451
      2. group Id
        FG001
        num Subjects
        452
      3. group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        451
      2. group Id
        FG001
        num Subjects
        451
      3. group Id
        FG002
        num Subjects
        0
      type
      Participants Received Treatment
    3. achievements
      1. group Id
        FG000
        num Subjects
        254
      2. group Id
        FG001
        num Subjects
        299
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        197
      2. group Id
        FG001
        num Subjects
        153
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Double-Blind (DB, as of ~31May2005)
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        19
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        19
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        9
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        37
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        28
      type
      Study terminated by Sponsor
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Per Investigator, not protocol driven
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Switched to commercial drug
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      type
      Switched to commercial drug (code error)
    8. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Missing
    9. reasons
      1. group Id
        FG000
        num Subjects
        19
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        9
      type
      No record of treatment discontinuation
    10. reasons
      1. group Id
        FG000
        num Subjects
        35
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        83
      type
      Did not enter OL/ Sorafenib only phase
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        254
      2. comment
        Placebo treatment ended \~ 31May2005. Those who continued, switched to receive Sorafenib.
        group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        299
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        219
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        216
      type
      Entered OL With Sorafenib Only Phase
    3. achievements
      1. group Id
        FG000
        num Subjects
        120
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        143
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        134
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        156
      type
      NOT COMPLETED
    title
    Open Label-Sorafenib Only [30Jun2008]
pre Assignment Details
Enrollment included outpatients with documented unresectable and/or metastatic RCC (Renal Cell Carcinoma), and subjects who had 1 prior systemic therapy for advanced disease on which the subject progressed, at least 1 unidimensional measurable lesion, intermediate or low Motzer risk score, life expectancy of 12 weeks.
recruitment Details
From randomization start on 01 Dec 2003 to 31 May 2005 \[last subject randomized\]. One subject randomized in Placebo did not receive treatment. This study was conducted at 120 centers from 19 countries.
Complete source fields
groups
  1. description
    Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily).
    id
    FG000
    title
    Sorafenib (Nexavar, BAY43-9006)
  2. description
    Subjects received matching placebo tablets administered orally twice a day. \[until \~31 May 2005\]
    id
    FG001
    title
    Placebo
  3. description
    Subjects received matching placebo tablets administered orally twice a day(as of \~31 May 2005) when after unblinding subjects switched over to receive Sorafenib orally administered as 2 x 200 mg tablets bid (twice daily).
    id
    FG002
    title
    Placebo Randomized, Switch to Sorafenib; Sorafenib Period Only
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        22
      2. group Id
        FG001
        num Subjects
        17
      3. group Id
        FG002
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        0
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        11
      3. group Id
        FG002
        num Subjects
        0
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Protocol Violation
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Non-compliant with Study medication
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Unknown reason.
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Protocol driven decision point
    8. reasons
      1. group Id
        FG000
        num Subjects
        165
      2. group Id
        FG001
        num Subjects
        114
      3. group Id
        FG002
        num Subjects
        0
      type
      entered Open Label (OL); Sorafenib only
    9. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Subject did not receive treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        451
      2. group Id
        FG001
        num Subjects
        452
      3. group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        451
      2. group Id
        FG001
        num Subjects
        451
      3. group Id
        FG002
        num Subjects
        0
      type
      Participants Received Treatment
    3. achievements
      1. group Id
        FG000
        num Subjects
        254
      2. group Id
        FG001
        num Subjects
        299
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        197
      2. group Id
        FG001
        num Subjects
        153
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Double-Blind (DB, as of ~31May2005)
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        19
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        19
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        9
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        37
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        28
      type
      Study terminated by Sponsor
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Per Investigator, not protocol driven
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Switched to commercial drug
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      type
      Switched to commercial drug (code error)
    8. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Missing
    9. reasons
      1. group Id
        FG000
        num Subjects
        19
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        9
      type
      No record of treatment discontinuation
    10. reasons
      1. group Id
        FG000
        num Subjects
        35
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        83
      type
      Did not enter OL/ Sorafenib only phase
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        254
      2. comment
        Placebo treatment ended \~ 31May2005. Those who continued, switched to receive Sorafenib.
        group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        299
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        219
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        216
      type
      Entered OL With Sorafenib Only Phase
    3. achievements
      1. group Id
        FG000
        num Subjects
        120
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        143
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        134
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        156
      type
      NOT COMPLETED
    title
    Open Label-Sorafenib Only [30Jun2008]
pre Assignment Details
Enrollment included outpatients with documented unresectable and/or metastatic RCC (Renal Cell Carcinoma), and subjects who had 1 prior systemic therapy for advanced disease on which the subject progressed, at least 1 unidimensional measurable lesion, intermediate or low Motzer risk score, life expectancy of 12 weeks.
recruitment Details
From randomization start on 01 Dec 2003 to 31 May 2005 \[last subject randomized\]. One subject randomized in Placebo did not receive treatment. This study was conducted at 120 centers from 19 countries.

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

Preserved source evidence · Not medical advice