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NCT01236053 · ADVERSE EVENTS

Adverse events

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.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Not reported
Other-event reporting threshold
0%

This is a retrospective study of pre-existing medical record and/or health insurance claims data; all data are de-identified, and thus no assessments of Serious or Non-serious Adverse Events are possible.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
All-Cancer: Cases

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.

0 / 00 / 0Not reported / Not reported
All-Cancer: Controls

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.

0 / 00 / 0Not reported / Not reported
Stomach Cancer: Cases

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.

0 / 00 / 0Not reported / Not reported
Stomach Cancer: Controls

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.

0 / 00 / 0Not reported / Not reported
Anal Cancer: Cases

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.

0 / 00 / 0Not reported / Not reported
Anal Cancer: Controls

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.

0 / 00 / 0Not reported / Not reported
Lung Cancer: Cases

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.

0 / 00 / 0Not reported / Not reported
Lung Cancer: Controls

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.

0 / 00 / 0Not reported / Not reported
Bone/Joint Cancer: Cases

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.

0 / 00 / 0Not reported / Not reported
Bone/Joint Cancer: Controls

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.

0 / 00 / 0Not reported / Not reported
Breast Cancer: Cases

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.

0 / 00 / 0Not reported / Not reported
Breast Cancer: Controls

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.

0 / 00 / 0Not reported / Not reported
Penile Cancer: Cases

Incidence of penile 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.

0 / 00 / 0Not reported / Not reported
Penile Cancer: Controls

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.

0 / 00 / 0Not reported / Not reported
Bladder Cancer: Cases

Incidence of bladder 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.

0 / 00 / 0Not reported / Not reported
Bladder Cancer: Controls

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.

0 / 00 / 0Not reported / Not reported
Other Nervous System Cancer: Cases

Incidence of other nervous system 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.

0 / 00 / 0Not reported / Not reported
Other Nervous System Cancer: Controls

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.

0 / 00 / 0Not reported / Not reported
Pancreatic Cancer: Cases

Incidence of pancreatic 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.

0 / 00 / 0Not reported / Not reported
Pancreatic Cancer: Controls

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.

0 / 00 / 0Not reported / Not reported
Renal Cancer: Cases

Incidence of renal 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.

0 / 00 / 0Not reported / Not reported
Renal Cancer: Controls

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.

0 / 00 / 0Not reported / Not reported

Group identifiers: EG000: All-Cancer: Cases · EG001: All-Cancer: Controls · EG002: Stomach Cancer: Cases · EG003: Stomach Cancer: Controls · EG004: Anal Cancer: Cases · EG005: Anal Cancer: Controls · EG006: Lung Cancer: Cases · EG007: Lung Cancer: Controls · EG008: Bone/Joint Cancer: Cases · EG009: Bone/Joint Cancer: Controls · EG010: Breast Cancer: Cases · EG011: Breast Cancer: Controls · EG012: Penile Cancer: Cases · EG013: Penile Cancer: Controls · EG014: Bladder Cancer: Cases · EG015: Bladder Cancer: Controls · EG016: Other Nervous System Cancer: Cases · EG017: Other Nervous System Cancer: Controls · EG018: Pancreatic Cancer: Cases · EG019: Pancreatic Cancer: Controls · EG020: Renal Cancer: Cases · EG021: Renal Cancer: Controls

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    Other reported adverse events

    Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

      Complete source fields
      description
      This is a retrospective study of pre-existing medical record and/or health insurance claims data; all data are de-identified, and thus no assessments of Serious or Non-serious Adverse Events are possible.
      event 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
        EG000
        other Num Affected
        0
        other Num At Risk
        0
        serious Num Affected
        0
        serious Num At Risk
        0
        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
        EG001
        other Num Affected
        0
        other Num At Risk
        0
        serious Num Affected
        0
        serious Num At Risk
        0
        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
        EG002
        other Num Affected
        0
        other Num At Risk
        0
        serious Num Affected
        0
        serious Num At Risk
        0
        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
        EG003
        other Num Affected
        0
        other Num At Risk
        0
        serious Num Affected
        0
        serious Num At Risk
        0
        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
        EG004
        other Num Affected
        0
        other Num At Risk
        0
        serious Num Affected
        0
        serious Num At Risk
        0
        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
        EG005
        other Num Affected
        0
        other Num At Risk
        0
        serious Num Affected
        0
        serious Num At Risk
        0
        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
        EG006
        other Num Affected
        0
        other Num At Risk
        0
        serious Num Affected
        0
        serious Num At Risk
        0
        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
        EG007
        other Num Affected
        0
        other Num At Risk
        0
        serious Num Affected
        0
        serious Num At Risk
        0
        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
        EG008
        other Num Affected
        0
        other Num At Risk
        0
        serious Num Affected
        0
        serious Num At Risk
        0
        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
        EG009
        other Num Affected
        0
        other Num At Risk
        0
        serious Num Affected
        0
        serious Num At Risk
        0
        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
        EG010
        other Num Affected
        0
        other Num At Risk
        0
        serious Num Affected
        0
        serious Num At Risk
        0
        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
        EG011
        other Num Affected
        0
        other Num At Risk
        0
        serious Num Affected
        0
        serious Num At Risk
        0
        title
        Breast Cancer: Controls
      frequency Threshold
      0

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      Preserved source evidence · Not medical advice