Gabapentin and Risk of Pancreatic Cancer and Renal Cancer (GPRD)
Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT01138124
Collaborator
(none)
54,202
5
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Study Design
Study Type:
Observational
Actual Enrollment
:
54202 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Risk of Pancreatic Cancer and Renal Cancer in Patients Exposed to Gabapentin in the United Kingdom General Practice Research Database
Study Start Date
:
Mar 1, 2010
Actual Primary Completion Date
:
Aug 1, 2010
Actual Study Completion Date
:
Aug 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Drug: Gabapentin prescriptions
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.
|
Outcome Measures
Primary Outcome Measures
- Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin [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]
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).
- Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Number of Gabapentin 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]
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).
- Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin [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]
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).
- Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin [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]
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).
- Number of Renal Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin [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.]
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).
- Number of Renal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin 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.]
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).
- Number of Renal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin [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.]
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).
- Number of Renal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin [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.]
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).
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Cases and controls will be required to have at least 2 years of follow-up in the study cohort before their index date (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.)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- GlaxoSmithKline
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01138124
Other Study ID Numbers:
- 114427
- EPI40634
- WEUSKOP4774
First Posted:
Jun 7, 2010
Last Update Posted:
May 30, 2017
Last Verified:
May 1, 2017
Keywords provided by GlaxoSmithKline
Additional relevant MeSH terms:
Study Results
Participant Flow
| 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 treatment are recorded in the course of routine medical practice. |
|---|---|
| Pre-assignment Detail | 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. |
| Arm/Group Title | Pancreatic Cancer Cases | Pancreatic Cancer Controls | Renal Cancer Cases | Renal Cancer Controls |
|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. |
| Period Title: Overall Study | ||||
| STARTED | 3149 | 30026 | 1981 | 19046 |
| COMPLETED | 3149 | 30026 | 1981 | 19046 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Pancreatic Cancer Cases | Pancreatic Cancer Controls | Renal Cancer Cases | Renal Cancer Controls | Total |
|---|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. | Total of all reporting groups |
| Overall Participants | 3149 | 30026 | 1981 | 19046 | 54202 |
| Age, Customized (Number) [Number] | |||||
| <40 years |
18
0.6%
|
199
0.7%
|
43
2.2%
|
446
2.3%
|
706
1.3%
|
| 40-49 years |
86
2.7%
|
897
3%
|
134
6.8%
|
1348
7.1%
|
2465
4.5%
|
| 50-59 years |
367
11.7%
|
3616
12%
|
355
17.9%
|
3418
17.9%
|
7756
14.3%
|
| 60-69 years |
748
23.8%
|
7234
24.1%
|
528
26.7%
|
5199
27.3%
|
13709
25.3%
|
| 70-79 years |
1033
32.8%
|
10092
33.6%
|
594
30%
|
5604
29.4%
|
17323
32%
|
| >=80 years |
897
28.5%
|
7988
26.6%
|
327
16.5%
|
3031
15.9%
|
12243
22.6%
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
1603
50.9%
|
15316
51%
|
759
38.3%
|
7273
38.2%
|
24951
46%
|
| Male |
1546
49.1%
|
14710
49%
|
1222
61.7%
|
11773
61.8%
|
29251
54%
|
| Number of participants with the indicated duration of follow-up from GPRD registration to index date (participants) [Number] | |||||
| 2-3 years |
173
5.5%
|
1460
4.9%
|
129
6.5%
|
1081
5.7%
|
2843
5.2%
|
| 4-5 years |
185
5.9%
|
1509
5%
|
117
5.9%
|
1135
6%
|
2946
5.4%
|
| 6-7 years |
237
7.5%
|
2007
6.7%
|
141
7.1%
|
1280
6.7%
|
3665
6.8%
|
| >=8 years |
2554
81.1%
|
25050
83.4%
|
1594
80.5%
|
15550
81.6%
|
44748
82.6%
|
| Number of participants with the indicated duration of follow-up from GPRD study cohort entry to ID (participants) [Number] | |||||
| 2-3 years |
446
14.2%
|
4121
13.7%
|
286
14.4%
|
2653
13.9%
|
7506
13.8%
|
| 4-5 years |
396
12.6%
|
3656
12.2%
|
226
11.4%
|
2122
11.1%
|
6400
11.8%
|
| 6-7 years |
447
14.2%
|
4213
14%
|
246
12.4%
|
2338
12.3%
|
7244
13.4%
|
| >=8 years |
1860
59.1%
|
18036
60.1%
|
1223
61.7%
|
11933
62.7%
|
33052
61%
|
| Number of participants with the indicated body mass index (BMI) (participants) [Number] | |||||
| <18.5 kg/m^2 |
25
0.8%
|
203
0.7%
|
18
0.9%
|
110
0.6%
|
356
0.7%
|
| 18.5 to 24.99 kg/m^2 |
459
14.6%
|
3678
12.2%
|
237
12%
|
2236
11.7%
|
6610
12.2%
|
| 25 to 29.99 kg/m^2 |
457
14.5%
|
4250
14.2%
|
326
16.5%
|
2938
15.4%
|
7971
14.7%
|
| >=30 kg/m^2 |
291
9.2%
|
2476
8.2%
|
250
12.6%
|
1773
9.3%
|
4790
8.8%
|
| Missing |
1917
60.9%
|
19419
64.7%
|
1150
58.1%
|
11989
62.9%
|
34475
63.6%
|
| Number of participants with the indicated smoking status (participants) [Number] | |||||
| Current Smoker |
731
23.2%
|
4857
16.2%
|
476
24%
|
3555
18.7%
|
9619
17.7%
|
| Ex-smoker |
768
24.4%
|
6626
22.1%
|
524
26.5%
|
4589
24.1%
|
12507
23.1%
|
| Never Smoked |
1385
44%
|
15249
50.8%
|
867
43.8%
|
9121
47.9%
|
26622
49.1%
|
| Status Unknown |
265
8.4%
|
3294
11%
|
114
5.8%
|
1781
9.4%
|
5454
10.1%
|
| Number of participants with the indicated medical conditions in Pancreatic Cancer Cases/Controls (participants) [Number] | |||||
| Diabetes (>=2 years prior to index date [ID]) |
363
11.5%
|
2137
7.1%
|
0
0%
|
0
0%
|
2500
4.6%
|
| Epilepsy |
53
1.7%
|
458
1.5%
|
0
0%
|
0
0%
|
511
0.9%
|
| Neuropathic Pain |
737
23.4%
|
6616
22%
|
0
0%
|
0
0%
|
7353
13.6%
|
| Chronic Pancreatitis (>=2 years prior to ID) |
13
0.4%
|
17
0.1%
|
0
0%
|
0
0%
|
30
0.1%
|
| Number of participants with the indicated medical conditions/drug use in Renal Cancer Cases/Controls (participants) [Number] | |||||
| Hypertension |
0
0%
|
0
0%
|
1159
58.5%
|
9113
47.8%
|
10272
19%
|
| Diuretic use |
0
0%
|
0
0%
|
875
44.2%
|
6396
33.6%
|
7271
13.4%
|
| Diabetes |
0
0%
|
0
0%
|
240
12.1%
|
1598
8.4%
|
1838
3.4%
|
| Epilepsy |
0
0%
|
0
0%
|
33
1.7%
|
303
1.6%
|
336
0.6%
|
| Neuropathic Pain |
0
0%
|
0
0%
|
428
21.6%
|
4018
21.1%
|
4446
8.2%
|
Outcome Measures
| Title | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin |
|---|---|
| Description | 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). |
| Time Frame | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Cases | Controls |
|---|---|---|
| Arm/Group Description | Cases | Controls |
| Measure Participants | 3149 | 30026 |
| Ever (without 2 year lag) |
56
1.8%
|
253
0.8%
|
| Never (without 2 year lag) |
3093
98.2%
|
29773
99.2%
|
| Ever (with 2 year lag) |
24
0.8%
|
143
0.5%
|
| Never (with 2 year lag) |
3125
99.2%
|
29883
99.5%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Unadjusted Odds Ratio |
| Estimated Value | 2.04 | |
| Confidence Interval |
(2-Sided) 95% 1.51 to 2.75 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Ever (without 2 year lag)" and "Never (without 2 year lag)". | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0001 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Odds Ratio |
| Estimated Value | 1.82 | |
| Confidence Interval |
(2-Sided) 95% 1.34 to 2.46 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Ever (without 2 year lag)" and "Never (without 2 year lag)". Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0627 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Unadjusted Odds Ratio |
| Estimated Value | 1.52 | |
| Confidence Interval |
(2-Sided) 95% 0.98 to 2.36 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Ever (with 2 year lag)" and "Never (with 2 year lag)". | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2183 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Odds Ratio |
| Estimated Value | 1.33 | |
| Confidence Interval |
(2-Sided) 95% 0.85 to 2.08 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Ever (with 2 year lag)" and "Never (with 2 year lag)". Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy. | |
| Title | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions |
|---|---|
| Description | 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). |
| Time Frame | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Cases | Controls |
|---|---|---|
| Arm/Group Description | Cases | Controls |
| Measure Participants | 3149 | 30026 |
| Never (without 2 year lag) |
3093
98.2%
|
29773
99.2%
|
| Tertile 1 (without 2 year lag) |
30
1%
|
99
0.3%
|
| Tertile 2 (without 2 year lag) |
12
0.4%
|
64
0.2%
|
| Tertile 3 (without 2 year lag) |
14
0.4%
|
90
0.3%
|
| Never (with 2 year lag) |
3125
99.2%
|
29883
99.5%
|
| Tertile 1 (with 2 year lag) |
14
0.4%
|
48
0.2%
|
| Tertile 2 (with 2 year lag) |
3
0.1%
|
49
0.2%
|
| Tertile 3 (with 2 year lag) |
7
0.2%
|
46
0.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Unadjusted Odds Ratio |
| Estimated Value | 2.82 | |
| Confidence Interval |
(2-Sided) 95% 1.86 to 4.28 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 1 (without 2 year lag)" and "Never (without 2 year lag)". | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Odds Ratio |
| Estimated Value | 2.53 | |
| Confidence Interval |
(2-Sided) 95% 1.66 to 3.85 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 1 (without 2 year lag)" and "Never (without 2 year lag)". Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Unadjusted Odds Ratio |
| Estimated Value | 2.75 | |
| Confidence Interval |
(2-Sided) 95% 1.51 to 5.03 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 1 (with 2 year lag)" and "Never (with 2 year lag)". | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0042 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Odds Ratio |
| Estimated Value | 2.44 | |
| Confidence Interval |
(2-Sided) 95% 1.32 to 4.49 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 1 (with 2 year lag)" and "Never (with 2 year lag)". Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy. | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0645 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Unadjusted Odds Ratio |
| Estimated Value | 1.8 | |
| Confidence Interval |
(2-Sided) 95% 0.97 to 3.36 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 2 (without 2 year lag)" and "Never (without 2 year lag)". | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1232 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Odds Ratio |
| Estimated Value | 1.65 | |
| Confidence Interval |
(2-Sided) 95% 0.87 to 3.11 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 2 (without 2 year lag)" and "Never (without 2 year lag)". Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy. | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3160 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Unadjusted Odds Ratio |
| Estimated Value | 0.55 | |
| Confidence Interval |
(2-Sided) 95% 0.17 to 1.78 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 2 (with 2 year lag)" and "Never (with 2 year lag)". | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2234 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Odds Ratio |
| Estimated Value | 0.48 | |
| Confidence Interval |
(2-Sided) 95% 0.15 to 1.57 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 2 (with 2 year lag)" and "Never (with 2 year lag)". Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy. | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3071 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Unadjusted Odds Ratio |
| Estimated Value | 1.35 | |
| Confidence Interval |
(2-Sided) 95% 0.76 to 2.42 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 3 (without 2 year lag)" and "Never (without 2 year lag)". | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6062 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Odds Ratio |
| Estimated Value | 1.17 | |
| Confidence Interval |
(2-Sided) 95% 0.65 to 2.11 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 3 (without 2 year lag)" and "Never (without 2 year lag)". Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy. | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5205 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Unadjusted Odds Ratio |
| Estimated Value | 1.31 | |
| Confidence Interval |
(2-Sided) 95% 0.58 to 2.97 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 3 (with 2 year lag)" and "Never (with 2 year lag)". | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8042 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Odds Ratio |
| Estimated Value | 1.11 | |
| Confidence Interval |
(2-Sided) 95% 0.48 to 2.57 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 3 (with 2 year lag)" and "Never (with 2 year lag)". Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy. | |
| Title | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin |
|---|---|
| Description | 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). |
| Time Frame | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Cases | Controls |
|---|---|---|
| Arm/Group Description | Cases | Controls |
| Measure Participants | 3149 | 30026 |
| Never (without 2 year lag) |
3093
98.2%
|
29773
99.2%
|
| Tertile 1 (without 2 year lag) |
28
0.9%
|
83
0.3%
|
| Tertile 2 (without 2 year lag) |
14
0.4%
|
79
0.3%
|
| Tertile 3 (without 2 year lag) |
14
0.4%
|
91
0.3%
|
| Never (with 2 year lag) |
3125
99.2%
|
29883
99.5%
|
| Tertile 1 (with 2 year lag) |
13
0.4%
|
44
0.1%
|
| Tertile 2 (with 2 year lag) |
4
0.1%
|
47
0.2%
|
| Tertile 3 (with 2 year lag) |
7
0.2%
|
52
0.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Unadjusted Odds Ratio |
| Estimated Value | 3.15 | |
| Confidence Interval |
(2-Sided) 95% 2.04 to 4.86 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 1 (without 2 year lag)" and "Never (without 2 year lag)". | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Odds Ratio |
| Estimated Value | 2.88 | |
| Confidence Interval |
(2-Sided) 95% 1.85 to 4.46 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 1 (without 2 year lag)" and "Never (without 2 year lag)". Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0015 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Unadjusted Odds Ratio |
| Estimated Value | 2.75 | |
| Confidence Interval |
(2-Sided) 95% 1.47 to 5.13 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 1 (with 2 year lag)" and "Never (with 2 year lag)". | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0053 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Odds Ratio |
| Estimated Value | 2.45 | |
| Confidence Interval |
(2-Sided) 95% 1.31 to 4.62 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 1 (with 2 year lag)" and "Never (with 2 year lag)". Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy. | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0777 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Unadjusted Odds Ratio |
| Estimated Value | 1.68 | |
| Confidence Interval |
(2-Sided) 95% 0.94 to 2.99 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 2 (without 2 year lag)" and "Never (without 2 year lag)". | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1762 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Odds Ratio |
| Estimated Value | 1.5 | |
| Confidence Interval |
(2-Sided) 95% 0.83 to 2.69 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 2 (without 2 year lag)" and "Never (without 2 year lag)". Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy. | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6990 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Unadjusted Odds Ratio |
| Estimated Value | 0.82 | |
| Confidence Interval |
(2-Sided) 95% 0.29 to 2.28 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 2 (with 2 year lag)" and "Never (with 2 year lag)". | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5274 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Odds Ratio |
| Estimated Value | 0.72 | |
| Confidence Interval |
(2-Sided) 95% 0.26 to 2.01 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 2 (with 2 year lag)" and "Never (with 2 year lag)". Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy. | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3245 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Unadjusted Odds Ratio |
| Estimated Value | 1.34 | |
| Confidence Interval |
(2-Sided) 95% 0.75 to 2.39 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 3 (without 2 year lag)" and "Never (without 2 year lag)". | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6388 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Odds Ratio |
| Estimated Value | 1.15 | |
| Confidence Interval |
(2-Sided) 95% 0.64 to 2.07 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 3 (without 2 year lag)" and "Never (without 2 year lag)". Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy. | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.796 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Unadjusted Odds Ratio |
| Estimated Value | 1.11 | |
| Confidence Interval |
(2-Sided) 95% 0.49 to 2.51 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 3 (with 2 year lag)" and "Never (with 2 year lag)". | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8772 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Odds Ratio |
| Estimated Value | 0.94 | |
| Confidence Interval |
(2-Sided) 95% 0.41 to 2.15 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 3 (with 2 year lag)" and "Never (with 2 year lag)". Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy. | |
| Title | Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin |
|---|---|
| Description | 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). |
| Time Frame | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Cases | Controls |
|---|---|---|
| Arm/Group Description | Cases | Controls |
| Measure Participants | 3149 | 30026 |
| Never (without 2 year lag) |
3093
98.2%
|
29773
99.2%
|
| Tertile 1 (without 2 year lag) |
28
0.9%
|
88
0.3%
|
| Tertile 2 (without 2 year lag) |
14
0.4%
|
74
0.2%
|
| Tertile 3 (without 2 year lag) |
14
0.4%
|
91
0.3%
|
| Never (with 2 year lag) |
3125
99.2%
|
29883
99.5%
|
| Tertile 1 (with 2 year lag) |
11
0.3%
|
46
0.2%
|
| Tertile 2 (with 2 year lag) |
7
0.2%
|
47
0.2%
|
| Tertile 3 (with 2 year lag) |
6
0.2%
|
50
0.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Unadjusted Odds Ratio |
| Estimated Value | 2.90 | |
| Confidence Interval |
(2-Sided) 95% 1.88 to 4.47 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 1 (without 2 year lag)" and "Never (without 2 year lag)". | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Odds Ratio |
| Estimated Value | 2.65 | |
| Confidence Interval |
(2-Sided) 95% 1.71 to 4.11 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 1 (without 2 year lag)" and "Never (without 2 year lag)". Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0212 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Unadjusted Odds Ratio |
| Estimated Value | 2.19 | |
| Confidence Interval |
(2-Sided) 95% 1.12 to 4.25 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 1 (with 2 year lag)" and "Never (with 2 year lag)". | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0522 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Odds Ratio |
| Estimated Value | 1.95 | |
| Confidence Interval |
(2-Sided) 95% 0.99 to 3.81 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 1 (with 2 year lag)" and "Never (with 2 year lag)". Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy. | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0337 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Unadjusted Odds Ratio |
| Estimated Value | 1.87 | |
| Confidence Interval |
(2-Sided) 95% 1.05 to 3.32 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 2 (without 2 year lag)" and "Never (without 2 year lag)". | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0947 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Odds Ratio |
| Estimated Value | 1.64 | |
| Confidence Interval |
(2-Sided) 95% 0.92 to 2.95 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 2 (without 2 year lag)" and "Never (without 2 year lag)". Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy. | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3928 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Unadjusted Odds Ratio |
| Estimated Value | 1.42 | |
| Confidence Interval |
(2-Sided) 95% 0.64 to 3.16 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 2 (with 2 year lag)" and "Never (with 2 year lag)". | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6502 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Odds Ratio |
| Estimated Value | 1.21 | |
| Confidence Interval |
(2-Sided) 95% 0.54 to 2.72 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 2 (with 2 year lag)" and "Never (with 2 year lag)". Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy. | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3275 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Unadjusted Odds Ratio |
| Estimated Value | 1.34 | |
| Confidence Interval |
(2-Sided) 95% 0.75 to 2.39 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 3 (without 2 year lag)" and "Never (without 2 year lag)". | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6365 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Odds Ratio |
| Estimated Value | 1.15 | |
| Confidence Interval |
(2-Sided) 95% 0.64 to 2.08 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 3 (without 2 year lag)" and "Never (without 2 year lag)". Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy. | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9858 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Unadjusted Odds Ratio |
| Estimated Value | 1.01 | |
| Confidence Interval |
(2-Sided) 95% 0.42 to 2.41 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 3 (with 2 year lag)" and "Never (with 2 year lag)". | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7671 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Odds Ratio |
| Estimated Value | 0.87 | |
| Confidence Interval |
(2-Sided) 95% 0.36 to 2.12 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 3 (with 2 year lag)" and "Never (with 2 year lag)". Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy. | |
| Title | Number of Renal Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin |
|---|---|
| Description | 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). |
| Time Frame | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Cases | Controls |
|---|---|---|
| Arm/Group Description | Cases | Controls |
| Measure Participants | 1981 | 19046 |
| Ever (without 2 year lag) |
32
1%
|
166
0.6%
|
| Never (without 2 year lag) |
1949
61.9%
|
18880
62.9%
|
| Ever (with 2 year lag) |
13
0.4%
|
76
0.3%
|
| Never (with 2 year lag) |
1968
62.5%
|
18970
63.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0031 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Unadjusted Odds Ratio |
| Estimated Value | 1.79 | |
| Confidence Interval |
(2-Sided) 95% 1.22 to 2.63 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Ever (without 2 year lag)" and "Never (without 2 year lag)". | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0095 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Odds Ratio |
| Estimated Value | 1.68 | |
| Confidence Interval |
(2-Sided) 95% 1.13 to 2.49 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Ever (without 2 year lag)" and "Never (without 2 year lag)". Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0970 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Unadjusted Odds Ratio |
| Estimated Value | 1.65 | |
| Confidence Interval |
(2-Sided) 95% 0.91 to 2.99 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Ever (with 2 year lag)" and "Never (with 2 year lag)". | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1123 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Odds Ratio |
| Estimated Value | 1.63 | |
| Confidence Interval |
(2-Sided) 95% 0.89 to 2.97 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Ever (with 2 year lag)" and "Never (with 2 year lag)". Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy. | |
| Title | Number of Renal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions |
|---|---|
| Description | 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). |
| Time Frame | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Cases | Controls |
|---|---|---|
| Arm/Group Description | Cases | Controls |
| Measure Participants | 1981 | 19046 |
| Never (without 2 year lag) |
1949
61.9%
|
18880
62.9%
|
| Tertile 1 (without 2 year lag) |
16
0.5%
|
58
0.2%
|
| Tertile 2 (without 2 year lag) |
11
0.3%
|
55
0.2%
|
| Tertile 3 (without 2 year lag) |
5
0.2%
|
53
0.2%
|
| Never (with 2 year lag) |
1968
62.5%
|
18970
63.2%
|
| Tertile 1 (with 2 year lag) |
6
0.2%
|
27
0.1%
|
| Tertile 2 (with 2 year lag) |
4
0.1%
|
28
0.1%
|
| Tertile 3 (with 2 year lag) |
3
0.1%
|
21
0.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0012 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Unadjusted Odds Ratio |
| Estimated Value | 2.53 | |
| Confidence Interval |
(2-Sided) 95% 1.44 to 4.44 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 1 (without 2 year lag)" and "Never (without 2 year lag)" | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0034 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Odds Ratio |
| Estimated Value | 2.34 | |
| Confidence Interval |
(2-Sided) 95% 1.32 to 4.14 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | 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. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0856 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Unadjusted Odds Ratio |
| Estimated Value | 2.18 | |
| Confidence Interval |
(2-Sided) 95% 0.9 to 5.32 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | 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. | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0996 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Odds Ratio |
| Estimated Value | 2.14 | |
| Confidence Interval |
(2-Sided) 95% 0.87 to 5.28 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | 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. | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0563 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Unadjusted Odds Ratio |
| Estimated Value | 1.89 | |
| Confidence Interval |
(2-Sided) 95% 0.98 to 3.63 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 2 (without 2 year lag)" and "Never (without 2 year lag)". | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0896 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Odds Ratio |
| Estimated Value | 1.77 | |
| Confidence Interval |
(2-Sided) 95% 0.92 to 3.43 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | 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. | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5308 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Unadjusted Odds Ratio |
| Estimated Value | 1.4 | |
| Confidence Interval |
(2-Sided) 95% 0.49 to 4.01 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 2 (with 2 year lag)" and "Never (with 2 year lag)". | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5458 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Odds Ratio |
| Estimated Value | 1.39 | |
| Confidence Interval |
(2-Sided) 95% 0.48 to 4.02 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | 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. | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7744 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Unadjusted Odds Ratio |
| Estimated Value | 0.87 | |
| Confidence Interval |
(2-Sided) 95% 0.35 to 2.19 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 3 (without 2 year lag)" and "Never (without 2 year lag)". | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6999 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Odds Ratio |
| Estimated Value | 0.83 | |
| Confidence Interval |
(2-Sided) 95% 0.33 to 2.11 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | 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. | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6528 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Unadjusted Odds Ratio |
| Estimated Value | 1.32 | |
| Confidence Interval |
(2-Sided) 95% 0.39 to 4.47 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 3 (with 2 year lag)" and "Never (with 2 year lag)". | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6722 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Odds Ratio |
| Estimated Value | 1.3 | |
| Confidence Interval |
(2-Sided) 95% 0.38 to 4.47 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | 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. | |
| Title | Number of Renal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin |
|---|---|
| Description | 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). |
| Time Frame | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Cases | Controls |
|---|---|---|
| Arm/Group Description | Cases | Controls |
| Measure Participants | 1981 | 19046 |
| Never (without 2 year lag) |
1949
61.9%
|
18880
62.9%
|
| Tertile 1 (without 2 year lag) |
15
0.5%
|
44
0.1%
|
| Tertile 2 (without 2 year lag) |
10
0.3%
|
67
0.2%
|
| Tertile 3 (without 2 year lag) |
7
0.2%
|
55
0.2%
|
| Never (with 2 year lag) |
1968
62.5%
|
18970
63.2%
|
| Tertile 1 (with 2 year lag) |
6
0.2%
|
23
0.1%
|
| Tertile 2 (with 2 year lag) |
3
0.1%
|
31
0.1%
|
| Tertile 3 (with 2 year lag) |
4
0.1%
|
22
0.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Unadjusted Odds Ratio |
| Estimated Value | 3.24 | |
| Confidence Interval |
(2-Sided) 95% 1.79 to 5.85 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 1 (without 2 year lag)" and "Never (without 2 year lag)". | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0005 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Odds Ratio |
| Estimated Value | 2.9 | |
| Confidence Interval |
(2-Sided) 95% 1.59 to 5.28 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | 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. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.042 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Unadjusted Odds Ratio |
| Estimated Value | 2.54 | |
| Confidence Interval |
(2-Sided) 95% 1.03 to 6.25 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 1 (with 2 year lag)" and "Never (with 2 year lag)". | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0603 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Odds Ratio |
| Estimated Value | 2.4 | |
| Confidence Interval |
(2-Sided) 95% 0.96 to 5.98 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | 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. | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3762 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Unadjusted Odds Ratio |
| Estimated Value | 1.35 | |
| Confidence Interval |
(2-Sided) 95% 0.69 to 2.65 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 2 (without 2 year lag)" and "Never (without 2 year lag)". | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4073 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Odds Ratio |
| Estimated Value | 1.33 | |
| Confidence Interval |
(2-Sided) 95% 0.68 to 2.63 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | 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. | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9294 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Unadjusted Odds Ratio |
| Estimated Value | 0.95 | |
| Confidence Interval |
(2-Sided) 95% 0.29 to 3.12 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 2 (with 2 year lag)" and "Never (with 2 year lag)". | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9875 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Odds Ratio |
| Estimated Value | 0.99 | |
| Confidence Interval |
(2-Sided) 95% 0.3 to 3.29 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | 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. | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.66 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Unadjusted Odds Ratio |
| Estimated Value | 1.19 | |
| Confidence Interval |
(2-Sided) 95% 0.54 to 2.63 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 3 (without 2 year lag)" and "Never (without 2 year lag)". | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8110 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Odds Ratio |
| Estimated Value | 1.1 | |
| Confidence Interval |
(2-Sided) 95% 0.5 to 2.45 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | 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. | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3336 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Unadjusted Odds Ratio |
| Estimated Value | 1.7 | |
| Confidence Interval |
(2-Sided) 95% 0.58 to 4.96 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 3 (with 2 year lag)" and "Never (with 2 year lag)". | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3782 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Odds Ratio |
| Estimated Value | 1.63 | |
| Confidence Interval |
(2-Sided) 95% 0.55 to 4.84 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | 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. | |
| Title | Number of Renal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin |
|---|---|
| Description | 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). |
| Time Frame | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Cases | Controls |
|---|---|---|
| Arm/Group Description | Cases | Controls |
| Measure Participants | 1981 | 19046 |
| Never (without 2 year lag) |
1949
61.9%
|
18880
62.9%
|
| Tertile 1 (without 2 year lag) |
9
0.3%
|
45
0.1%
|
| Tertile 2 (without 2 year lag) |
17
0.5%
|
63
0.2%
|
| Tertile 3 (without 2 year lag) |
6
0.2%
|
58
0.2%
|
| Never (with 2 year lag) |
1968
62.5%
|
18970
63.2%
|
| Tertile 1 (with 2 year lag) |
5
0.2%
|
24
0.1%
|
| Tertile 2 (with 2 year lag) |
5
0.2%
|
26
0.1%
|
| Tertile 3 (with 2 year lag) |
3
0.1%
|
26
0.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0841 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Unadjusted Odds Ratio |
| Estimated Value | 1.89 | |
| Confidence Interval |
(2-Sided) 95% 0.92 to 3.88 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 1 (without 2 year lag)" and "Never (without 2 year lag)". | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1313 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Odds Ratio |
| Estimated Value | 1.75 | |
| Confidence Interval |
(2-Sided) 95% 0.85 to 3.63 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | 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. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1488 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Unadjusted Odds Ratio |
| Estimated Value | 2.03 | |
| Confidence Interval |
(2-Sided) 95% 0.78 to 5.34 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 1 (with 2 year lag)" and "Never (with 2 year lag)". | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1495 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Odds Ratio |
| Estimated Value | 2.05 | |
| Confidence Interval |
(2-Sided) 95% 0.77 to 5.46 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | 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. | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0013 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Unadjusted Odds Ratio |
| Estimated Value | 2.44 | |
| Confidence Interval |
(2-Sided) 95% 1.42 to 4.22 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 2 (without 2 year lag)" and "Never (without 2 year lag)". | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0026 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Odds Ratio |
| Estimated Value | 2.34 | |
| Confidence Interval |
(2-Sided) 95% 1.35 to 4.07 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | 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. | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2421 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Unadjusted Odds Ratio |
| Estimated Value | 1.78 | |
| Confidence Interval |
(2-Sided) 95% 0.68 to 4.69 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 2 (with 2 year lag)" and "Never (with 2 year lag)". | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2899 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Odds Ratio |
| Estimated Value | 1.7 | |
| Confidence Interval |
(2-Sided) 95% 0.64 to 4.53 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | 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. | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9723 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Unadjusted Odds Ratio |
| Estimated Value | 0.99 | |
| Confidence Interval |
(2-Sided) 95% 0.42 to 2.29 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 3 (without 2 year lag)" and "Never (without 2 year lag)". | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8206 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Odds Ratio |
| Estimated Value | 0.91 | |
| Confidence Interval |
(2-Sided) 95% 0.39 to 2.13 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | 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. | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8135 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Unadjusted Odds Ratio |
| Estimated Value | 1.15 | |
| Confidence Interval |
(2-Sided) 95% 0.35 to 3.82 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Comparison: "Tertile 3 (with 2 year lag)" and "Never (with 2 year lag)". | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Cases, Controls |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8173 |
| Comments | ||
| Method | Conditional Logistic Regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted Odds Ratio |
| Estimated Value | 1.15 | |
| Confidence Interval |
(2-Sided) 95% 0.34 to 3.86 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | 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. | |
Adverse Events
| Time Frame | ||||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting 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. | |||||||
| Arm/Group Title | Pancreatic Cancer Cases | Pancreatic Cancer Controls | Renal Cancer Cases | Renal Cancer Controls | ||||
| Arm/Group Description | 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. | 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. | 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. | 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. | ||||
All Cause Mortality |
||||||||
| Pancreatic Cancer Cases | Pancreatic Cancer Controls | Renal Cancer Cases | Renal Cancer Controls | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| Pancreatic Cancer Cases | Pancreatic Cancer Controls | Renal Cancer Cases | Renal Cancer Controls | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Pancreatic Cancer Cases | Pancreatic Cancer Controls | Renal Cancer Cases | Renal Cancer Controls | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | GSK Response Center |
|---|---|
| Organization | GlaxoSmithKline |
| Phone | 866-435-7343 |
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01138124
Other Study ID Numbers:
- 114427
- EPI40634
- WEUSKOP4774
First Posted:
Jun 7, 2010
Last Update Posted:
May 30, 2017
Last Verified:
May 1, 2017