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| ID | Type | Description | Link |
|---|---|---|---|
| EPI40634 | Other Identifier | GSK | |
| WEUSKOP4774 | Other Identifier | GSK |
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High doses of gabapentin are associated with pancreatic acinar cell tumors in rats, but there has been no post marketing pancreatic carcinogenicity signal with gabapentin as reported by spontaneous reports in the Adverse Events Reporting System or in the published literature. In a published case-control screening study of the association of gabapentin with 55 cancers, the only cancer that met the screening criteria for possibly increased cancer risk with gabapentin exposure was renal (including renal pelvis) cancer. This association was judged to be likely due to or substantially accentuated by confounding by cigarette smoking, hypertension, and lifestyle (Cancer Causes Control 2009;20:1821-1835).
The primary objective of this study is to determine whether exposure to gabapentin is associated with an increased risk of developing pancreatic cancer or renal cancer in the United Kingdom (UK) General Practice Research Database (GPRD). Almost all members of the UK population are registered with a General Practice, which centralizes the medical information not only from the general practitioners themselves but also from specialist referrals and hospital attendances. Over 487 General Practices contribute data to the GPRD.
The study cohort from which cases and controls are drawn is all subjects in the GPRD 1993-2008. Gabapentin was approved in the UK in May 1993. Entry into the study cohort begins Jan 1, 1993 for all those who are registered in GPRD before that time, and at the time of registration if later than Jan 1, 1993. Patients with a first diagnosis of the respective cancer 1995-2008 are risk set matched with up to 10 controls within the same General Practice for age at cohort entry (within two years), sex, and year of entry into the study cohort (within one year). For cases, the index date is the date of first diagnosis of the respective cancer. The index date for controls is set as the date at which the follow-up time from cohort entry is the same as the case. The index date is chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Cases and controls will be required to have at least 2 years of follow-up in the study cohort before their index date. Data on gabapentin prescriptions are obtained for cases and controls from study cohort entry to the index date.
Crude and adjusted odds ratios and 95% confidence intervals (CI) will be produced from conditional logistic regression models, with additional analyses evaluating for latency and dose-response. For pancreatic cancer, covariates are smoking, body mass index, diabetes, epilepsy, neuropathic pain, and chronic pancreatitis. For renal cancer, covariates are smoking, body mass index, diabetes, hypertension, diuretic use, epilepsy, and neuropathic pain.
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 anonymised and used to develop a patient cohort. All diagnoses and treatment are recorded in the course of routine medical practice. Actual number of patients could be less than , as it is possible for a patient to be represented in more than one of the four arms (See "Participant Flow: Overall Study" Table) because of the risk set sampling.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UK GPRD 1993-2008 | The study cohort from which cases and controls are drawn is all subjects in the United Kingdom (UK) General Practice Research Database (GPRD) 1993-2008. Each member of the UK population is registered with a General Practice, which centralizes the medical information not only from the general practitioners themselves but also from specialist referrals and hospital attendances. Over 487 General Practices contribute data to the GPRD. Entry into the study cohort begins Jan 1, 1993 for all those who are registered in GPRD before that time, and at the time of registration if later than Jan 1, 1993. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin prescriptions | Drug | The exposure of interest is gabapentin use as defined by prescriptions recorded by the GPRD general practitioner (British National Formulary codes). Data on prescriptions for gabapentin will be extracted for each case and control from entry into the study cohort up to the index date (the exposure window). Gabapentin exposure will be parameterized as follows: (1) Ever versus never exposed; (2) Number of prescriptions; (3) Duration of exposure; and (4) Cumulative dose. These parameterizations will also be examined with a 2 year lag time from the index date, limiting the exposure window from entry into the study cohort up to 2 years prior to the index date. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin | Incident pancreatic cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin prescription from cohort entry to index date. With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). | The case index date (ID) was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case |
| Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions | Incident pancreatic cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin exposure from cohort entry to index date. With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Tertiles without 2 year lag: Tertile 1 (1-2 prescriptions),Tertile 2 (3-8 prescriptions), and Tertile 3 (9-218 prescriptions). Tertile's with 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-10 prescriptions),Tertile 3 (11-191 prescriptions). | The case index date (ID) was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case |
| Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin | Incident pancreatic cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin exposure from cohort entry to index date. With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Tertile's without 2 year lag: Tertile 1 (0.01 - 1.55 months), Tertile 2 (1.56 - 6.44 months), and Tertile 3 (6.45 - 78.36 months). Tertile's with 2 year lag: Tertile 1 (0.01 - 1.78 months), Tertile 2 (1.79 - 7.20 months), and Tertile 3 (7.21 - 64.13 months). |
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Inclusion Criteria:
Exclusion Criteria:
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The study cohort from which cases and controls are drawn is all subjects in the UK GPRD 1993-2008. Entry into the study cohort begins Jan 1, 1993 for all those who are registered in GPRD before that time, and at the time of registration if later than Jan 1, 1993. Follow-up ends Dec 31, 2008, or earlier if the respective cancer is diagnosed, or if the subject leaves the GPRD for any reason including death. There are several advantages to the GPRD dataset for this study. It is a large dataset with detailed longitudinal prescription data, and long term follow-up (mean 7 years) to allow for latency in carcinogenicity. It provides good representation of the elderly who are disproportionately affected by pancreatic and renal cancers, and routinely includes data recorded by general practitioners on potential risk factors such as smoking and body mass index.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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Actual number of patients may be less, as it is possible for a patient to be represented in more than one of the four arms (See "Participant Flow: Overall Study" Table) because of the risk set sampling.
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 treatment are recorded in the course of routine medical practice.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pancreatic Cancer Cases | Incident pancreatic cancer, defined as first time pancreatic cancer diagnosis (READ/ Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the GPRD study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Subjects were required to have at least 2 years of follow-up prior to the index date. The index date for cases was the date of incident pancreatic cancer diagnosis. Exocrine pancreatic cancer, endocrine pancreatic cancer, and carcinoma in situ were included. Cancer metastatic to the pancreas was excluded. |
| FG001 | Pancreatic Cancer Controls | Pancreatic 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. |
| FG002 | Renal Cancer Cases | Incident renal cancer, defined as first time renal cancer diagnosis (READ/OXMIS codes) in the GPRD study cohort. Entry into the GPRD study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Subjects were required to have at least 2 years of follow-up prior to the index date. The index date for cases was the date of incident renal cancer diagnosis. Renal cell carcinoma and renal pelvis cancer were included; Wilm's tumor and cancer metastatic to kidney were excluded. |
| FG003 | Renal Cancer Controls | Renal cancer cases were risk set matched with up to 10 controls for sex, age at 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pancreatic Cancer Cases | Incident pancreatic cancer, defined as first time pancreatic cancer diagnosis (READ/OXMIS codes) in the GPRD study cohort. Entry into the GPRD study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Subjects were required to have at least 2 years of follow-up prior to the index date. The index date for cases was the date of incident pancreatic cancer diagnosis. Exocrine pancreatic cancer, endocrine pancreatic cancer, and carcinoma in situ were included. Cancer metastatic to the pancreas was excluded. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number of participants with the indicated age at index date. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin | Incident pancreatic cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin prescription from cohort entry to index date. With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). | Cases and controls were drawn from the GPRD study cohort. Entry into the study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Follow-up ended Dec 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. | Posted | Number | participants | The case index date (ID) was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pancreatic Cancer Cases | Incident pancreatic cancer, defined as first time pancreatic cancer diagnosis (READ/ Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the GPRD study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Subjects were required to have at least 2 years of follow-up prior to the index date. The index date for cases was the date of incident pancreatic cancer diagnosis. Exocrine pancreatic cancer, endocrine pancreatic cancer, and carcinoma in situ were included. Cancer metastatic to the pancreas was excluded. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D012148 | Restless Legs Syndrome |
| D004827 | Epilepsy |
| D009437 | Neuralgia |
| D050500 | Pancreatitis, Chronic |
| D006973 | Hypertension |
| D010190 | Pancreatic Neoplasms |
| D003920 | Diabetes Mellitus |
| D007680 | Kidney Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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|
| The case index date (ID) was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case |
| Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin | Incident pancreatic cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin exposure from cohort entry to index date. With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Tertile's without 2 year lag: Tertile 1 (0.01 - 33.6 grams), Tertile 2 (33.7 - 185.0 grams), and Tertile 3 (185.1 - 7500.2 grams). Tertile's with 2 year lag: Tertile 1 (0.01 - 39.0 grams), Tertile 2 (39.1 - 210.0 grams), and Tertile 3 (210.1 - 5623.8 grams). | The case index date (ID) was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case |
| Number of Renal Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin | Incident renal cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin prescription from cohort entry to index date. With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). | The case index date (ID) was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case. |
| Number of Renal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions | Incident renal cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin exposure from cohort entry to index date. With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Tertiles without 2 year lag: Tertile 1 (1-2 prescriptions),Tertile 2 (3-8 prescriptions), and Tertile 3 (9-218 prescriptions). Tertile's with 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-10 prescriptions),Tertile 3 (11-191 prescriptions). | The case index date (ID) was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case. |
| Number of Renal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin | Incident renal cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin exposure from cohort entry to index date. With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Tertile's without 2 year lag: Tertile 1 (0.01 - 1.55 months), Tertile 2 (1.56 - 6.44 months), and Tertile 3 (6.45 - 78.36 months). Tertile's with 2 year lag: Tertile 1 (0.01 - 1.78 months), Tertile 2 (1.79 - 7.20 months), and Tertile 3 (7.21 - 64.13 months). | The case index date (ID) was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case. |
| Number of Renal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin | Incident renal cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin exposure from cohort entry to index date. With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Tertile's without 2 year lag: Tertile 1 (0.01 - 33.6 grams), Tertile 2 (33.7 - 185.0 grams), and Tertile 3 (185.1 - 7500.2 grams). Tertile's with 2 year lag: Tertile 1 (0.01 - 39.0 grams), Tertile 2 (39.1 - 210.0 grams), and Tertile 3 (210.1 - 5623.8 grams). | The case index date (ID) was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case. |
| BG001 | Pancreatic Cancer Controls | Pancreatic cancer cases were risk set matched with up to 10 controls for sex, age at 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. |
| BG002 | Renal Cancer Cases | Incident renal cancer, defined as first time renal cancer diagnosis (READ/OXMIS codes) in the GPRD study cohort. Entry into the GPRD study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Subjects were required to have at least 2 years of follow-up prior to the index date. The index date for cases was the date of incident renal cancer diagnosis. Renal cell carcinoma and renal pelvis cancer were included; Wilm's tumor and cancer metastatic to kidney were excluded. |
| BG003 | Renal Cancer Controls | Renal cancer cases were risk set matched with up to 10 controls for sex, age at 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. |
| BG004 | Total | Total of all reporting groups |
| Number |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Number of participants with the indicated duration of follow-up from GPRD registration to index date | Number | participants |
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| Number of participants with the indicated duration of follow-up from GPRD study cohort entry to ID | Entry into the GPRD study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Subjects were required to have at least 2 years of follow-up prior to the index date (ID). | Number | participants |
|
| Number of participants with the indicated body mass index (BMI) | BMI is calculated as weight in kilograms (between one and three years prior to the index date, closest to 1 year prior to index date) divided by height in meters (one year or longer prior to index date) squared (m^2). | Number | participants |
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| Number of participants with the indicated smoking status | Number | participants |
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| Number of participants with the indicated medical conditions in Pancreatic Cancer Cases/Controls | Medical conditions up to the index date by READ/OXMIS codes were analyzed. | Number | participants |
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| Number of participants with the indicated medical conditions/drug use in Renal Cancer Cases/Controls | Medical conditions up to the index date by READ/OXMIS codes were analyzed. Drug use up to the index date according to British National Formulary codes was analyzed. | Number | participants |
|
| Cases |
Cases |
| OG001 | Controls | Controls |
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| Primary | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions | Incident pancreatic cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin exposure from cohort entry to index date. With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Tertiles without 2 year lag: Tertile 1 (1-2 prescriptions),Tertile 2 (3-8 prescriptions), and Tertile 3 (9-218 prescriptions). Tertile's with 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-10 prescriptions),Tertile 3 (11-191 prescriptions). | Cases and controls were drawn from the GPRD study cohort. Entry into the study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Follow-up ended Dec 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. | Posted | Number | participants | The case index date (ID) was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case |
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| Primary | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin | Incident pancreatic cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin exposure from cohort entry to index date. With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Tertile's without 2 year lag: Tertile 1 (0.01 - 1.55 months), Tertile 2 (1.56 - 6.44 months), and Tertile 3 (6.45 - 78.36 months). Tertile's with 2 year lag: Tertile 1 (0.01 - 1.78 months), Tertile 2 (1.79 - 7.20 months), and Tertile 3 (7.21 - 64.13 months). | Cases and controls were drawn from the GPRD study cohort. Entry into the study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Follow-up ended Dec 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. | Posted | Number | participants | The case index date (ID) was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case |
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| Primary | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin | Incident pancreatic cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin exposure from cohort entry to index date. With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Tertile's without 2 year lag: Tertile 1 (0.01 - 33.6 grams), Tertile 2 (33.7 - 185.0 grams), and Tertile 3 (185.1 - 7500.2 grams). Tertile's with 2 year lag: Tertile 1 (0.01 - 39.0 grams), Tertile 2 (39.1 - 210.0 grams), and Tertile 3 (210.1 - 5623.8 grams). | Cases and controls were drawn from the GPRD study cohort. Entry into the study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Follow-up ended Dec 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. | Posted | Number | participants | The case index date (ID) was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case |
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| Primary | Number of Renal Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin | Incident renal cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin prescription from cohort entry to index date. With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). | Cases and controls were drawn from the GPRD study cohort. Entry into the study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Follow-up ended Dec 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. | Posted | Number | participants | The case index date (ID) was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case. |
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| Primary | Number of Renal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions | Incident renal cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin exposure from cohort entry to index date. With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Tertiles without 2 year lag: Tertile 1 (1-2 prescriptions),Tertile 2 (3-8 prescriptions), and Tertile 3 (9-218 prescriptions). Tertile's with 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-10 prescriptions),Tertile 3 (11-191 prescriptions). | Cases and controls were drawn from the GPRD study cohort. Entry into the study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Follow-up ended Dec 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. | Posted | Number | participants | The case index date (ID) was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case. |
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| Primary | Number of Renal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin | Incident renal cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin exposure from cohort entry to index date. With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Tertile's without 2 year lag: Tertile 1 (0.01 - 1.55 months), Tertile 2 (1.56 - 6.44 months), and Tertile 3 (6.45 - 78.36 months). Tertile's with 2 year lag: Tertile 1 (0.01 - 1.78 months), Tertile 2 (1.79 - 7.20 months), and Tertile 3 (7.21 - 64.13 months). | Cases and controls were drawn from the GPRD study cohort. Entry into the study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Follow-up ended Dec 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. | Posted | Number | participants | The case index date (ID) was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case. |
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| Primary | Number of Renal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin | Incident renal cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin exposure from cohort entry to index date. With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Tertile's without 2 year lag: Tertile 1 (0.01 - 33.6 grams), Tertile 2 (33.7 - 185.0 grams), and Tertile 3 (185.1 - 7500.2 grams). Tertile's with 2 year lag: Tertile 1 (0.01 - 39.0 grams), Tertile 2 (39.1 - 210.0 grams), and Tertile 3 (210.1 - 5623.8 grams). | Cases and controls were drawn from the GPRD study cohort. Entry into the study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Follow-up ended Dec 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. | Posted | Number | participants | The case index date (ID) was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case. |
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| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Pancreatic Cancer Controls | Pancreatic 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. | 0 | 0 | 0 | 0 |
| EG002 | Renal Cancer Cases | Incident renal cancer, defined as first time renal cancer diagnosis (READ/OXMIS codes) in the GPRD study cohort. Entry into the GPRD study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Subjects were required to have at least 2 years of follow-up prior to the index date. The index date for cases was the date of incident renal cancer diagnosis. Renal cell carcinoma and renal pelvis cancer were included; Wilm's tumor and cancer metastatic to kidney were excluded. | 0 | 0 | 0 | 0 |
| EG003 | Renal Cancer Controls | Renal cancer cases were risk set matched with up to 10 controls for sex, age at 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. | 0 | 0 | 0 | 0 |
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D020447 |
| Parasomnias |
| D001523 | Mental Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010195 | Pancreatitis |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004700 | Endocrine System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| Tertile 2 (without 2 year lag) |
|
| Tertile 3 (without 2 year lag) |
|
| Never (with 2 year lag) |
|
| Tertile 1 (with 2 year lag) |
|
| Tertile 2 (with 2 year lag) |
|
| Tertile 3 (with 2 year lag) |
|
| <0.0001 |
| Adjusted Odds Ratio |
| 2.53 |
| 2-Sided |
| 95 |
| 1.66 |
| 3.85 |
Comparison: "Tertile 1 (without 2 year lag)" and "Never (without 2 year lag)". Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy |
| Superiority or Other |
| Conditional Logistic Regression | 0.001 | Unadjusted Odds Ratio | 2.75 | 2-Sided | 95 | 1.51 | 5.03 | Comparison: "Tertile 1 (with 2 year lag)" and "Never (with 2 year lag)". | Superiority or Other |
| Conditional Logistic Regression | 0.0042 | Adjusted Odds Ratio | 2.44 | 2-Sided | 95 | 1.32 | 4.49 | Comparison: "Tertile 1 (with 2 year lag)" and "Never (with 2 year lag)". Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy. | Superiority or Other |
| Conditional Logistic Regression | 0.0645 | Unadjusted Odds Ratio | 1.8 | 2-Sided | 95 | 0.97 | 3.36 | Comparison: "Tertile 2 (without 2 year lag)" and "Never (without 2 year lag)". | Superiority or Other |
| Conditional Logistic Regression | 0.1232 | Adjusted Odds Ratio | 1.65 | 2-Sided | 95 | 0.87 | 3.11 | Comparison: "Tertile 2 (without 2 year lag)" and "Never (without 2 year lag)". Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy. | Superiority or Other |
| Conditional Logistic Regression | 0.3160 | Unadjusted Odds Ratio | 0.55 | 2-Sided | 95 | 0.17 | 1.78 | Comparison: "Tertile 2 (with 2 year lag)" and "Never (with 2 year lag)". | Superiority or Other |
| Conditional Logistic Regression | 0.2234 | Adjusted Odds Ratio | 0.48 | 2-Sided | 95 | 0.15 | 1.57 | Comparison: "Tertile 2 (with 2 year lag)" and "Never (with 2 year lag)". Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy. | Superiority or Other |
| Conditional Logistic Regression | 0.3071 | Unadjusted Odds Ratio | 1.35 | 2-Sided | 95 | 0.76 | 2.42 | Comparison: "Tertile 3 (without 2 year lag)" and "Never (without 2 year lag)". | Superiority or Other |
| Conditional Logistic Regression | 0.6062 | Adjusted Odds Ratio | 1.17 | 2-Sided | 95 | 0.65 | 2.11 | Comparison: "Tertile 3 (without 2 year lag)" and "Never (without 2 year lag)". Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy. | Superiority or Other |
| Conditional Logistic Regression | 0.5205 | Unadjusted Odds Ratio | 1.31 | 2-Sided | 95 | 0.58 | 2.97 | Comparison: "Tertile 3 (with 2 year lag)" and "Never (with 2 year lag)". | Superiority or Other |
| Conditional Logistic Regression | 0.8042 | Adjusted Odds Ratio | 1.11 | 2-Sided | 95 | 0.48 | 2.57 | Comparison: "Tertile 3 (with 2 year lag)" and "Never (with 2 year lag)". Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy. | Superiority or Other |
| Tertile 2 (without 2 year lag) |
|
| Tertile 3 (without 2 year lag) |
|
| Never (with 2 year lag) |
|
| Tertile 1 (with 2 year lag) |
|
| Tertile 2 (with 2 year lag) |
|
| Tertile 3 (with 2 year lag) |
|
| <0.0001 |
| Adjusted Odds Ratio |
| 2.88 |
| 2-Sided |
| 95 |
| 1.85 |
| 4.46 |
Comparison: "Tertile 1 (without 2 year lag)" and "Never (without 2 year lag)". Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy. |
| Superiority or Other |
| Conditional Logistic Regression | 0.0015 | Unadjusted Odds Ratio | 2.75 | 2-Sided | 95 | 1.47 | 5.13 | Comparison: "Tertile 1 (with 2 year lag)" and "Never (with 2 year lag)". | Superiority or Other |
| Conditional Logistic Regression | 0.0053 | Adjusted Odds Ratio | 2.45 | 2-Sided | 95 | 1.31 | 4.62 | Comparison: "Tertile 1 (with 2 year lag)" and "Never (with 2 year lag)". Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy. | Superiority or Other |
| Conditional Logistic Regression | 0.0777 | Unadjusted Odds Ratio | 1.68 | 2-Sided | 95 | 0.94 | 2.99 | Comparison: "Tertile 2 (without 2 year lag)" and "Never (without 2 year lag)". | Superiority or Other |
| Conditional Logistic Regression | 0.1762 | Adjusted Odds Ratio | 1.5 | 2-Sided | 95 | 0.83 | 2.69 | Comparison: "Tertile 2 (without 2 year lag)" and "Never (without 2 year lag)". Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy. | Superiority or Other |
| Conditional Logistic Regression | 0.6990 | Unadjusted Odds Ratio | 0.82 | 2-Sided | 95 | 0.29 | 2.28 | Comparison: "Tertile 2 (with 2 year lag)" and "Never (with 2 year lag)". | Superiority or Other |
| Conditional Logistic Regression | 0.5274 | Adjusted Odds Ratio | 0.72 | 2-Sided | 95 | 0.26 | 2.01 | Comparison: "Tertile 2 (with 2 year lag)" and "Never (with 2 year lag)". Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy. | Superiority or Other |
| Conditional Logistic Regression | 0.3245 | Unadjusted Odds Ratio | 1.34 | 2-Sided | 95 | 0.75 | 2.39 | Comparison: "Tertile 3 (without 2 year lag)" and "Never (without 2 year lag)". | Superiority or Other |
| Conditional Logistic Regression | 0.6388 | Adjusted Odds Ratio | 1.15 | 2-Sided | 95 | 0.64 | 2.07 | Comparison: "Tertile 3 (without 2 year lag)" and "Never (without 2 year lag)". Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy. | Superiority or Other |
| Conditional Logistic Regression | 0.796 | Unadjusted Odds Ratio | 1.11 | 2-Sided | 95 | 0.49 | 2.51 | Comparison: "Tertile 3 (with 2 year lag)" and "Never (with 2 year lag)". | Superiority or Other |
| Conditional Logistic Regression | 0.8772 | Adjusted Odds Ratio | 0.94 | 2-Sided | 95 | 0.41 | 2.15 | Comparison: "Tertile 3 (with 2 year lag)" and "Never (with 2 year lag)". Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy. | Superiority or Other |
| Tertile 2 (without 2 year lag) |
|
| Tertile 3 (without 2 year lag) |
|
| Never (with 2 year lag) |
|
| Tertile 1 (with 2 year lag) |
|
| Tertile 2 (with 2 year lag) |
|
| Tertile 3 (with 2 year lag) |
|
| <0.0001 |
| Adjusted Odds Ratio |
| 2.65 |
| 2-Sided |
| 95 |
| 1.71 |
| 4.11 |
Comparison: "Tertile 1 (without 2 year lag)" and "Never (without 2 year lag)". Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy. |
| Superiority or Other |
| Conditional Logistic Regression | 0.0212 | Unadjusted Odds Ratio | 2.19 | 2-Sided | 95 | 1.12 | 4.25 | Comparison: "Tertile 1 (with 2 year lag)" and "Never (with 2 year lag)". | Superiority or Other |
| Conditional Logistic Regression | 0.0522 | Adjusted Odds Ratio | 1.95 | 2-Sided | 95 | 0.99 | 3.81 | Comparison: "Tertile 1 (with 2 year lag)" and "Never (with 2 year lag)". Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy. | Superiority or Other |
| Conditional Logistic Regression | 0.0337 | Unadjusted Odds Ratio | 1.87 | 2-Sided | 95 | 1.05 | 3.32 | Comparison: "Tertile 2 (without 2 year lag)" and "Never (without 2 year lag)". | Superiority or Other |
| Conditional Logistic Regression | 0.0947 | Adjusted Odds Ratio | 1.64 | 2-Sided | 95 | 0.92 | 2.95 | Comparison: "Tertile 2 (without 2 year lag)" and "Never (without 2 year lag)". Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy. | Superiority or Other |
| Conditional Logistic Regression | 0.3928 | Unadjusted Odds Ratio | 1.42 | 2-Sided | 95 | 0.64 | 3.16 | Comparison: "Tertile 2 (with 2 year lag)" and "Never (with 2 year lag)". | Superiority or Other |
| Conditional Logistic Regression | 0.6502 | Adjusted Odds Ratio | 1.21 | 2-Sided | 95 | 0.54 | 2.72 | Comparison: "Tertile 2 (with 2 year lag)" and "Never (with 2 year lag)". Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy. | Superiority or Other |
| Conditional Logistic Regression | 0.3275 | Unadjusted Odds Ratio | 1.34 | 2-Sided | 95 | 0.75 | 2.39 | Comparison: "Tertile 3 (without 2 year lag)" and "Never (without 2 year lag)". | Superiority or Other |
| Conditional Logistic Regression | 0.6365 | Adjusted Odds Ratio | 1.15 | 2-Sided | 95 | 0.64 | 2.08 | Comparison: "Tertile 3 (without 2 year lag)" and "Never (without 2 year lag)". Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy. | Superiority or Other |
| Conditional Logistic Regression | 0.9858 | Unadjusted Odds Ratio | 1.01 | 2-Sided | 95 | 0.42 | 2.41 | Comparison: "Tertile 3 (with 2 year lag)" and "Never (with 2 year lag)". | Superiority or Other |
| Conditional Logistic Regression | 0.7671 | Adjusted Odds Ratio | 0.87 | 2-Sided | 95 | 0.36 | 2.12 | Comparison: "Tertile 3 (with 2 year lag)" and "Never (with 2 year lag)". Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy. | Superiority or Other |
| Ever (with 2 year lag) |
|
| Never (with 2 year lag) |
|
| 0.0095 |
| Adjusted Odds Ratio |
| 1.68 |
| 2-Sided |
| 95 |
| 1.13 |
| 2.49 |
Comparison: "Ever (without 2 year lag)" and "Never (without 2 year lag)". Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy. |
| Superiority or Other |
| Conditional Logistic Regression | 0.0970 | Unadjusted Odds Ratio | 1.65 | 2-Sided | 95 | 0.91 | 2.99 | Comparison: "Ever (with 2 year lag)" and "Never (with 2 year lag)". | Superiority or Other |
| Conditional Logistic Regression | 0.1123 | Adjusted Odds Ratio | 1.63 | 2-Sided | 95 | 0.89 | 2.97 | Comparison: "Ever (with 2 year lag)" and "Never (with 2 year lag)". Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy. | Superiority or Other |
| Tertile 2 (without 2 year lag) |
|
| Tertile 3 (without 2 year lag) |
|
| Never (with 2 year lag) |
|
| Tertile 1 (with 2 year lag) |
|
| Tertile 2 (with 2 year lag) |
|
| Tertile 3 (with 2 year lag) |
|
| 0.0034 |
| Adjusted Odds Ratio |
| 2.34 |
| 2-Sided |
| 95 |
| 1.32 |
| 4.14 |
Comparison: "Tertile 1 (without 2 year lag)" and "Never (without 2 year lag)". Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy. |
| Superiority or Other |
| Conditional Logistic Regression | 0.0856 | Unadjusted Odds Ratio | 2.18 | 2-Sided | 95 | 0.9 | 5.32 | Comparison: "Tertile 1 (with 2 year lag)" and "Never (with 2 year lag)". Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy. | Superiority or Other |
| Conditional Logistic Regression | 0.0996 | Adjusted Odds Ratio | 2.14 | 2-Sided | 95 | 0.87 | 5.28 | Comparison: "Tertile 1 (with 2 year lag)" and "Never (with 2 year lag)". Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy. | Superiority or Other |
| Conditional Logistic Regression | 0.0563 | Unadjusted Odds Ratio | 1.89 | 2-Sided | 95 | 0.98 | 3.63 | Comparison: "Tertile 2 (without 2 year lag)" and "Never (without 2 year lag)". | Superiority or Other |
| Conditional Logistic Regression | 0.0896 | Adjusted Odds Ratio | 1.77 | 2-Sided | 95 | 0.92 | 3.43 | Comparison: "Tertile 2 (without 2 year lag)" and "Never (without 2 year lag)". Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy. | Superiority or Other |
| Conditional Logistic Regression | 0.5308 | Unadjusted Odds Ratio | 1.4 | 2-Sided | 95 | 0.49 | 4.01 | Comparison: "Tertile 2 (with 2 year lag)" and "Never (with 2 year lag)". | Superiority or Other |
| Conditional Logistic Regression | 0.5458 | Adjusted Odds Ratio | 1.39 | 2-Sided | 95 | 0.48 | 4.02 | Comparison: "Tertile 2 (with 2 year lag)" and "Never (with 2 year lag)". Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy. | Superiority or Other |
| Conditional Logistic Regression | 0.7744 | Unadjusted Odds Ratio | 0.87 | 2-Sided | 95 | 0.35 | 2.19 | Comparison: "Tertile 3 (without 2 year lag)" and "Never (without 2 year lag)". | Superiority or Other |
| Conditional Logistic Regression | 0.6999 | Adjusted Odds Ratio | 0.83 | 2-Sided | 95 | 0.33 | 2.11 | Comparison: "Tertile 3 (without 2 year lag)" and "Never (without 2 year lag)". Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy. | Superiority or Other |
| Conditional Logistic Regression | 0.6528 | Unadjusted Odds Ratio | 1.32 | 2-Sided | 95 | 0.39 | 4.47 | Comparison: "Tertile 3 (with 2 year lag)" and "Never (with 2 year lag)". | Superiority or Other |
| Conditional Logistic Regression | 0.6722 | Adjusted Odds Ratio | 1.3 | 2-Sided | 95 | 0.38 | 4.47 | Comparison: "Tertile 3 (with 2 year lag)" and "Never (with 2 year lag)". Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy. | Superiority or Other |
| Tertile 2 (without 2 year lag) |
|
| Tertile 3 (without 2 year lag) |
|
| Never (with 2 year lag) |
|
| Tertile 1 (with 2 year lag) |
|
| Tertile 2 (with 2 year lag) |
|
| Tertile 3 (with 2 year lag) |
|
| 0.0005 |
| Adjusted Odds Ratio |
| 2.9 |
| 2-Sided |
| 95 |
| 1.59 |
| 5.28 |
Comparison: "Tertile 1 (without 2 year lag)" and "Never (without 2 year lag)". Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy. |
| Superiority or Other |
| Conditional Logistic Regression | 0.042 | Unadjusted Odds Ratio | 2.54 | 2-Sided | 95 | 1.03 | 6.25 | Comparison: "Tertile 1 (with 2 year lag)" and "Never (with 2 year lag)". | Superiority or Other |
| Conditional Logistic Regression | 0.0603 | Adjusted Odds Ratio | 2.4 | 2-Sided | 95 | 0.96 | 5.98 | Comparison: "Tertile 1 (with 2 year lag)" and "Never (with 2 year lag)". Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy. | Superiority or Other |
| Conditional Logistic Regression | 0.3762 | Unadjusted Odds Ratio | 1.35 | 2-Sided | 95 | 0.69 | 2.65 | Comparison: "Tertile 2 (without 2 year lag)" and "Never (without 2 year lag)". | Superiority or Other |
| Conditional Logistic Regression | 0.4073 | Adjusted Odds Ratio | 1.33 | 2-Sided | 95 | 0.68 | 2.63 | Comparison: "Tertile 2 (without 2 year lag)" and "Never (without 2 year lag)". Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy. | Superiority or Other |
| Conditional Logistic Regression | 0.9294 | Unadjusted Odds Ratio | 0.95 | 2-Sided | 95 | 0.29 | 3.12 | Comparison: "Tertile 2 (with 2 year lag)" and "Never (with 2 year lag)". | Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.9875 | Adjusted Odds Ratio | 0.99 | 2-Sided | 95 | 0.3 | 3.29 | Comparison: "Tertile 2 (with 2 year lag)" and "Never (with 2 year lag)". Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy. | Superiority or Other |
| Conditional Logistic Regression | 0.66 | Unadjusted Odds Ratio | 1.19 | 2-Sided | 95 | 0.54 | 2.63 | Comparison: "Tertile 3 (without 2 year lag)" and "Never (without 2 year lag)". | Superiority or Other |
| Conditional Logistic Regression | 0.8110 | Adjusted Odds Ratio | 1.1 | 2-Sided | 95 | 0.5 | 2.45 | Comparison: "Tertile 3 (without 2 year lag)" and "Never (without 2 year lag)". Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy. | Superiority or Other |
| Conditional Logistic Regression | 0.3336 | Unadjusted Odds Ratio | 1.7 | 2-Sided | 95 | 0.58 | 4.96 | Comparison: "Tertile 3 (with 2 year lag)" and "Never (with 2 year lag)". | Superiority or Other |
| Conditional Logistic Regression | 0.3782 | Adjusted Odds Ratio | 1.63 | 2-Sided | 95 | 0.55 | 4.84 | Comparison: "Tertile 3 (with 2 year lag)" and "Never (with 2 year lag)". Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy. | Superiority or Other |
| Tertile 2 (without 2 year lag) |
|
| Tertile 3 (without 2 year lag) |
|
| Never (with 2 year lag) |
|
| Tertile 1 (with 2 year lag) |
|
| Tertile 2 (with 2 year lag) |
|
| Tertile 3 (with 2 year lag) |
|
| 0.1313 |
| Adjusted Odds Ratio |
| 1.75 |
| 2-Sided |
| 95 |
| 0.85 |
| 3.63 |
Comparison: "Tertile 1 (without 2 year lag)" and "Never (without 2 year lag)". Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy. |
| Superiority or Other |
| Conditional Logistic Regression | 0.1488 | Unadjusted Odds Ratio | 2.03 | 2-Sided | 95 | 0.78 | 5.34 | Comparison: "Tertile 1 (with 2 year lag)" and "Never (with 2 year lag)". | Superiority or Other |
| Conditional Logistic Regression | 0.1495 | Adjusted Odds Ratio | 2.05 | 2-Sided | 95 | 0.77 | 5.46 | Comparison: "Tertile 1 (with 2 year lag)" and "Never (with 2 year lag)". Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy. | Superiority or Other |
| Conditional Logistic Regression | 0.0013 | Unadjusted Odds Ratio | 2.44 | 2-Sided | 95 | 1.42 | 4.22 | Comparison: "Tertile 2 (without 2 year lag)" and "Never (without 2 year lag)". | Superiority or Other |
| Conditional Logistic Regression | 0.0026 | Adjusted Odds Ratio | 2.34 | 2-Sided | 95 | 1.35 | 4.07 | Comparison: "Tertile 2 (without 2 year lag)" and "Never (without 2 year lag)". Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy. | Superiority or Other |
| Conditional Logistic Regression | 0.2421 | Unadjusted Odds Ratio | 1.78 | 2-Sided | 95 | 0.68 | 4.69 | Comparison: "Tertile 2 (with 2 year lag)" and "Never (with 2 year lag)". | Superiority or Other |
| Conditional Logistic Regression | 0.2899 | Adjusted Odds Ratio | 1.7 | 2-Sided | 95 | 0.64 | 4.53 | Comparison: "Tertile 2 (with 2 year lag)" and "Never (with 2 year lag)". Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy. | Superiority or Other |
| Conditional Logistic Regression | 0.9723 | Unadjusted Odds Ratio | 0.99 | 2-Sided | 95 | 0.42 | 2.29 | Comparison: "Tertile 3 (without 2 year lag)" and "Never (without 2 year lag)". | Superiority or Other |
| Conditional Logistic Regression | 0.8206 | Adjusted Odds Ratio | 0.91 | 2-Sided | 95 | 0.39 | 2.13 | Comparison: "Tertile 3 (without 2 year lag)" and "Never (without 2 year lag)". Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy. | Superiority or Other |
| Conditional Logistic Regression | 0.8135 | Unadjusted Odds Ratio | 1.15 | 2-Sided | 95 | 0.35 | 3.82 | Comparison: "Tertile 3 (with 2 year lag)" and "Never (with 2 year lag)". | Superiority or Other |
| Conditional Logistic Regression | 0.8173 | Adjusted Odds Ratio | 1.15 | 2-Sided | 95 | 0.34 | 3.86 | Comparison: "Tertile 3 (with 2 year lag)" and "Never (with 2 year lag)". Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy. | Superiority or Other |