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NCT01236053 · FLOW

Participant flow

Cancer in Patients With Gabapentin (GPRD) · Source last updated 2017-07-06

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

groups
  1. description
    Incidence of all cancers defined as first time incident cancer diagnosis (READ/Oxford Medical Information System \[OXMIS\] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
    id
    FG000
    title
    All-Cancer: Cases
  2. description
    Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
    id
    FG001
    title
    All-Cancer: Controls
  3. description
    Incidence of stomach cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System \[OXMIS\] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
    id
    FG002
    title
    Stomach Cancer: Cases
  4. description
    Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
    id
    FG003
    title
    Stomach Cancer: Controls
  5. description
    Incidence of anal cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System \[OXMIS\] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
    id
    FG004
    title
    Anal Cancer: Cases
  6. description
    Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
    id
    FG005
    title
    Anal Cancer: Controls
  7. description
    Incidence of lung cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System \[OXMIS\] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
    id
    FG006
    title
    Lung Cancer: Cases
  8. description
    Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
    id
    FG007
    title
    Lung Cancer: Controls
  9. description
    Incidence of bone/joint cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System \[OXMIS\] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
    id
    FG008
    title
    Bone/Joint Cancer: Cases
  10. description
    Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
    id
    FG009
    title
    Bone/Joint Cancer: Controls
  11. description
    Incidence of breast cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System \[OXMIS\] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
    id
    FG010
    title
    Breast Cancer: Cases
  12. description
    Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
    id
    FG011
    title
    Breast Cancer: Controls
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        179138
      2. group Id
        FG001
        num Subjects
        1710950
      3. group Id
        FG002
        num Subjects
        1877
      4. group Id
        FG003
        num Subjects
        17853
      5. group Id
        FG004
        num Subjects
        212
      6. group Id
        FG005
        num Subjects
        2067
      7. group Id
        FG006
        num Subjects
        10855
      8. group Id
        FG007
        num Subjects
        102836
      9. group Id
        FG008
        num Subjects
        300
      10. group Id
        FG009
        num Subjects
        2935
      11. group Id
        FG010
        num Subjects
        19564
      12. group Id
        FG011
        num Subjects
        188924
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        179138
      2. group Id
        FG001
        num Subjects
        1710950
      3. group Id
        FG002
        num Subjects
        1877
      4. group Id
        FG003
        num Subjects
        17853
      5. group Id
        FG004
        num Subjects
        212
      6. group Id
        FG005
        num Subjects
        2067
      7. group Id
        FG006
        num Subjects
        10855
      8. group Id
        FG007
        num Subjects
        102836
      9. group Id
        FG008
        num Subjects
        300
      10. group Id
        FG009
        num Subjects
        2935
      11. group Id
        FG010
        num Subjects
        19564
      12. group Id
        FG011
        num Subjects
        188924
      type
      COMPLETED
    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
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Actual number of patients may be less, as it is possible for a patient to be represented in more than 1 of the 22 arms (See "Participant Flow: Overall Study" Table) because of the risk set sampling.
recruitment Details
Patients were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymized and used to develop a patient cohort. All diagnoses and treatments are recorded in the course of routine medical practice.
Complete source fields
groups
  1. description
    Incidence of all cancers defined as first time incident cancer diagnosis (READ/Oxford Medical Information System \[OXMIS\] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
    id
    FG000
    title
    All-Cancer: Cases
  2. description
    Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
    id
    FG001
    title
    All-Cancer: Controls
  3. description
    Incidence of stomach cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System \[OXMIS\] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
    id
    FG002
    title
    Stomach Cancer: Cases
  4. description
    Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
    id
    FG003
    title
    Stomach Cancer: Controls
  5. description
    Incidence of anal cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System \[OXMIS\] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
    id
    FG004
    title
    Anal Cancer: Cases
  6. description
    Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
    id
    FG005
    title
    Anal Cancer: Controls
  7. description
    Incidence of lung cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System \[OXMIS\] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
    id
    FG006
    title
    Lung Cancer: Cases
  8. description
    Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
    id
    FG007
    title
    Lung Cancer: Controls
  9. description
    Incidence of bone/joint cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System \[OXMIS\] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
    id
    FG008
    title
    Bone/Joint Cancer: Cases
  10. description
    Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
    id
    FG009
    title
    Bone/Joint Cancer: Controls
  11. description
    Incidence of breast cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System \[OXMIS\] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
    id
    FG010
    title
    Breast Cancer: Cases
  12. description
    Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
    id
    FG011
    title
    Breast Cancer: Controls
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        179138
      2. group Id
        FG001
        num Subjects
        1710950
      3. group Id
        FG002
        num Subjects
        1877
      4. group Id
        FG003
        num Subjects
        17853
      5. group Id
        FG004
        num Subjects
        212
      6. group Id
        FG005
        num Subjects
        2067
      7. group Id
        FG006
        num Subjects
        10855
      8. group Id
        FG007
        num Subjects
        102836
      9. group Id
        FG008
        num Subjects
        300
      10. group Id
        FG009
        num Subjects
        2935
      11. group Id
        FG010
        num Subjects
        19564
      12. group Id
        FG011
        num Subjects
        188924
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        179138
      2. group Id
        FG001
        num Subjects
        1710950
      3. group Id
        FG002
        num Subjects
        1877
      4. group Id
        FG003
        num Subjects
        17853
      5. group Id
        FG004
        num Subjects
        212
      6. group Id
        FG005
        num Subjects
        2067
      7. group Id
        FG006
        num Subjects
        10855
      8. group Id
        FG007
        num Subjects
        102836
      9. group Id
        FG008
        num Subjects
        300
      10. group Id
        FG009
        num Subjects
        2935
      11. group Id
        FG010
        num Subjects
        19564
      12. group Id
        FG011
        num Subjects
        188924
      type
      COMPLETED
    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
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Actual number of patients may be less, as it is possible for a patient to be represented in more than 1 of the 22 arms (See "Participant Flow: Overall Study" Table) because of the risk set sampling.
recruitment Details
Patients were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymized and used to develop a patient cohort. All diagnoses and treatments are recorded in the course of routine medical practice.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice