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NCT00092521 · FLOW

Participant flow

Cervical Intraepithelial Neoplasm (CIN)-Warts Efficacy Trial in Women (Gardasil)(V501-013)(COMPLETED) · Source last updated 2015-09-25

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

groups
  1. description
    The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent Human papillomavirus (HPV) vaccine. The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.
    id
    FG000
    title
    Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine
  2. description
    The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with the Monovalent (HPV 16) HPV vaccine. The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Monovalent (HPV 16) HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study. Group 2 Base Study Monovalent HPV (Type 16) Vaccine was not part of the pre-specified efficacy analysis population.
    id
    FG001
    title
    Group 2 - Base Study Monovalent HPV (Type 16) Vaccine
  3. description
    The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo. The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study.
    id
    FG002
    title
    Group 3 - Base Study Placebo
  4. description
    This group includes subjects who entered the extension including subjects who in the base study received fewer than the full three doses of Quadrivalent HPV vaccine during the base study (i.e., subjects who received placebo in the base study; subjects who received monovalent \[type 16\] HPV vaccine in the base study, or subjects who received \<=2 doses of quadrivalent HPV vaccine in the base study). Subjects who discontinued the base portion of the study could enter the extension portion of the study. In the extension period subjects designated as "Completed Period" are those who received three doses of quadrivalent HPV vaccine and completed all required follow-up visits. Subjects designated as "Not Completed" are those who: a) Received all three vaccinations, but did not complete follow-up; b) Did not receive all vaccinations, but completed follow-up, or c) Did not receive all vaccinations, and did not complete follow-up.
    id
    FG003
    title
    Group 4 - Quadrivalent Human Papillomavirus Vaccine Extension
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        0
      type
      Randomized Not Vaccinated
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        0
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        51
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        44
      4. group Id
        FG003
        num Subjects
        0
      type
      Lost to Follow-up
    5. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        0
      type
      Pregnancy
    6. reasons
      1. group Id
        FG000
        num Subjects
        59
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        62
      4. group Id
        FG003
        num Subjects
        0
      type
      Withdrawal by Subject
    7. reasons
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        18
      4. group Id
        FG003
        num Subjects
        0
      type
      Moved
    8. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Unblinded
    9. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      New Medical History (Not AE)
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        2723
      2. group Id
        FG001
        num Subjects
        304
      3. group Id
        FG002
        num Subjects
        2732
      4. group Id
        FG003
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        2583
      2. group Id
        FG001
        num Subjects
        290
      3. group Id
        FG002
        num Subjects
        2586
      4. group Id
        FG003
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        140
      2. group Id
        FG001
        num Subjects
        14
      3. group Id
        FG002
        num Subjects
        146
      4. group Id
        FG003
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Vaccination (Day 1 Through Month 7)
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        34
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        35
      4. group Id
        FG003
        num Subjects
        0
      type
      Subjects Continuing
    2. reasons
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        109
      3. group Id
        FG002
        num Subjects
        412
      4. group Id
        FG003
        num Subjects
        0
      type
      Subjects in Extension
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        113
      2. group Id
        FG001
        num Subjects
        14
      3. group Id
        FG002
        num Subjects
        108
      4. group Id
        FG003
        num Subjects
        0
      type
      Lost to Follow-up
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        0
      type
      Protocol Violation
    7. reasons
      1. group Id
        FG000
        num Subjects
        40
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        51
      4. group Id
        FG003
        num Subjects
        0
      type
      Withdrawal by Subject
    8. reasons
      1. group Id
        FG000
        num Subjects
        32
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        28
      4. group Id
        FG003
        num Subjects
        0
      type
      Moved
    9. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        0
      type
      Site Terminated
    10. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Travel
    11. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        0
      type
      Visits Compressed
    milestones
    1. achievements
      1. comment
        Includes subjects who did not receive 3 doses of vaccine/placebo but continued into the follow-up
        group Id
        FG000
        num Subjects
        2599
      2. comment
        Includes subjects who did not receive 3 doses of vaccine/placebo but continued into the follow-up
        group Id
        FG001
        num Subjects
        291
      3. comment
        Includes subjects who did not receive 3 doses of vaccine/placebo but continued into the follow-up
        group Id
        FG002
        num Subjects
        2607
      4. group Id
        FG003
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        2353
      2. group Id
        FG001
        num Subjects
        155
      3. group Id
        FG002
        num Subjects
        1959
      4. group Id
        FG003
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        246
      2. group Id
        FG001
        num Subjects
        136
      3. group Id
        FG002
        num Subjects
        648
      4. group Id
        FG003
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Follow-Up (After Month 7)
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        23
      type
      Excluded ineligible for extension
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        2
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        87
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        4
      type
      Pregnancy
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        2
      type
      Protocol Violation
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        46
      type
      Withdrawal by Subject
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        16
      type
      Moved
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        4
      type
      Site Terminated
    9. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        25
      type
      Unable/unwilling to return
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        844
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        829
      type
      Initiated Extension Study
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        801
      type
      Received >=1 Dose in Extension Study
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        635
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        209
      type
      NOT COMPLETED
    title
    Extension Study (Group 4)
recruitment Details
The study Protocol 013 (NCT00092521) (N =5759 total randomized) was comprised of two sub-studies: Protocol 011 (NCT00517309) (N=1877 total randomized) and Protocol 012 (NCT00092482) (N=3882 total randomized). Final safety data are presented in the results for Protocol 013 (NCT00092521): the final participant visit took place on 19 January 2009.
Complete source fields
groups
  1. description
    The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent Human papillomavirus (HPV) vaccine. The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.
    id
    FG000
    title
    Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine
  2. description
    The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with the Monovalent (HPV 16) HPV vaccine. The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Monovalent (HPV 16) HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study. Group 2 Base Study Monovalent HPV (Type 16) Vaccine was not part of the pre-specified efficacy analysis population.
    id
    FG001
    title
    Group 2 - Base Study Monovalent HPV (Type 16) Vaccine
  3. description
    The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo. The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study.
    id
    FG002
    title
    Group 3 - Base Study Placebo
  4. description
    This group includes subjects who entered the extension including subjects who in the base study received fewer than the full three doses of Quadrivalent HPV vaccine during the base study (i.e., subjects who received placebo in the base study; subjects who received monovalent \[type 16\] HPV vaccine in the base study, or subjects who received \<=2 doses of quadrivalent HPV vaccine in the base study). Subjects who discontinued the base portion of the study could enter the extension portion of the study. In the extension period subjects designated as "Completed Period" are those who received three doses of quadrivalent HPV vaccine and completed all required follow-up visits. Subjects designated as "Not Completed" are those who: a) Received all three vaccinations, but did not complete follow-up; b) Did not receive all vaccinations, but completed follow-up, or c) Did not receive all vaccinations, and did not complete follow-up.
    id
    FG003
    title
    Group 4 - Quadrivalent Human Papillomavirus Vaccine Extension
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        0
      type
      Randomized Not Vaccinated
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        0
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        51
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        44
      4. group Id
        FG003
        num Subjects
        0
      type
      Lost to Follow-up
    5. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        0
      type
      Pregnancy
    6. reasons
      1. group Id
        FG000
        num Subjects
        59
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        62
      4. group Id
        FG003
        num Subjects
        0
      type
      Withdrawal by Subject
    7. reasons
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        18
      4. group Id
        FG003
        num Subjects
        0
      type
      Moved
    8. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Unblinded
    9. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      New Medical History (Not AE)
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        2723
      2. group Id
        FG001
        num Subjects
        304
      3. group Id
        FG002
        num Subjects
        2732
      4. group Id
        FG003
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        2583
      2. group Id
        FG001
        num Subjects
        290
      3. group Id
        FG002
        num Subjects
        2586
      4. group Id
        FG003
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        140
      2. group Id
        FG001
        num Subjects
        14
      3. group Id
        FG002
        num Subjects
        146
      4. group Id
        FG003
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Vaccination (Day 1 Through Month 7)
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        34
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        35
      4. group Id
        FG003
        num Subjects
        0
      type
      Subjects Continuing
    2. reasons
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        109
      3. group Id
        FG002
        num Subjects
        412
      4. group Id
        FG003
        num Subjects
        0
      type
      Subjects in Extension
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        113
      2. group Id
        FG001
        num Subjects
        14
      3. group Id
        FG002
        num Subjects
        108
      4. group Id
        FG003
        num Subjects
        0
      type
      Lost to Follow-up
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        0
      type
      Protocol Violation
    7. reasons
      1. group Id
        FG000
        num Subjects
        40
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        51
      4. group Id
        FG003
        num Subjects
        0
      type
      Withdrawal by Subject
    8. reasons
      1. group Id
        FG000
        num Subjects
        32
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        28
      4. group Id
        FG003
        num Subjects
        0
      type
      Moved
    9. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        0
      type
      Site Terminated
    10. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Travel
    11. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        0
      type
      Visits Compressed
    milestones
    1. achievements
      1. comment
        Includes subjects who did not receive 3 doses of vaccine/placebo but continued into the follow-up
        group Id
        FG000
        num Subjects
        2599
      2. comment
        Includes subjects who did not receive 3 doses of vaccine/placebo but continued into the follow-up
        group Id
        FG001
        num Subjects
        291
      3. comment
        Includes subjects who did not receive 3 doses of vaccine/placebo but continued into the follow-up
        group Id
        FG002
        num Subjects
        2607
      4. group Id
        FG003
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        2353
      2. group Id
        FG001
        num Subjects
        155
      3. group Id
        FG002
        num Subjects
        1959
      4. group Id
        FG003
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        246
      2. group Id
        FG001
        num Subjects
        136
      3. group Id
        FG002
        num Subjects
        648
      4. group Id
        FG003
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Follow-Up (After Month 7)
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        23
      type
      Excluded ineligible for extension
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        2
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        87
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        4
      type
      Pregnancy
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        2
      type
      Protocol Violation
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        46
      type
      Withdrawal by Subject
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        16
      type
      Moved
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        4
      type
      Site Terminated
    9. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        25
      type
      Unable/unwilling to return
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        844
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        829
      type
      Initiated Extension Study
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        801
      type
      Received >=1 Dose in Extension Study
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        635
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        209
      type
      NOT COMPLETED
    title
    Extension Study (Group 4)
recruitment Details
The study Protocol 013 (NCT00092521) (N =5759 total randomized) was comprised of two sub-studies: Protocol 011 (NCT00517309) (N=1877 total randomized) and Protocol 012 (NCT00092482) (N=3882 total randomized). Final safety data are presented in the results for Protocol 013 (NCT00092521): the final participant visit took place on 19 January 2009.

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Preserved source evidence · Not medical advice