Trial Outcomes & Findings for Gabapentin and Risk of Pancreatic Cancer and Renal Cancer (GPRD) (NCT NCT01138124)
NCT ID: NCT01138124
Last Updated: 2017-05-30
Results Overview
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).
COMPLETED
54202 participants
The case index date (ID) was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case
2017-05-30
Participant Flow
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.
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.
Participant milestones
| Measure |
Pancreatic Cancer Cases
Incident pancreatic cancer, defined as first time pancreatic cancer diagnosis (READ/ Oxford Medical Information System \[OXMIS\] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the GPRD study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Subjects were required to have at least 2 years of follow-up prior to the index date. The index date for cases was the date of incident pancreatic cancer diagnosis. Exocrine pancreatic cancer, endocrine pancreatic cancer, and carcinoma in situ were included. Cancer metastatic to the pancreas was excluded.
|
Pancreatic Cancer Controls
Pancreatic cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site.
The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin.
|
Renal Cancer Cases
Incident renal cancer, defined as first time renal cancer diagnosis (READ/OXMIS codes) in the GPRD study cohort. Entry into the GPRD study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Subjects were required to have at least 2 years of follow-up prior to the index date. The index date for cases was the date of incident renal cancer diagnosis. Renal cell carcinoma and renal pelvis cancer were included; Wilm's tumor and cancer metastatic to kidney were excluded.
|
Renal Cancer Controls
Renal cancer cases were risk set matched with up to 10 controls for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3149
|
30026
|
1981
|
19046
|
|
Overall Study
COMPLETED
|
3149
|
30026
|
1981
|
19046
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gabapentin and Risk of Pancreatic Cancer and Renal Cancer (GPRD)
Baseline characteristics by cohort
| Measure |
Pancreatic Cancer Cases
n=3149 Participants
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 Controls
n=30026 Participants
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.
|
Renal Cancer Cases
n=1981 Participants
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 Controls
n=19046 Participants
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
n=54202 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
<40 years
|
18 Participants
n=99 Participants
|
199 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
446 Participants
n=7 Participants
|
706 Participants
n=31 Participants
|
|
Age, Customized
40-49 years
|
86 Participants
n=99 Participants
|
897 Participants
n=107 Participants
|
134 Participants
n=206 Participants
|
1348 Participants
n=7 Participants
|
2465 Participants
n=31 Participants
|
|
Age, Customized
50-59 years
|
367 Participants
n=99 Participants
|
3616 Participants
n=107 Participants
|
355 Participants
n=206 Participants
|
3418 Participants
n=7 Participants
|
7756 Participants
n=31 Participants
|
|
Age, Customized
60-69 years
|
748 Participants
n=99 Participants
|
7234 Participants
n=107 Participants
|
528 Participants
n=206 Participants
|
5199 Participants
n=7 Participants
|
13709 Participants
n=31 Participants
|
|
Age, Customized
70-79 years
|
1033 Participants
n=99 Participants
|
10092 Participants
n=107 Participants
|
594 Participants
n=206 Participants
|
5604 Participants
n=7 Participants
|
17323 Participants
n=31 Participants
|
|
Age, Customized
>=80 years
|
897 Participants
n=99 Participants
|
7988 Participants
n=107 Participants
|
327 Participants
n=206 Participants
|
3031 Participants
n=7 Participants
|
12243 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
1603 Participants
n=99 Participants
|
15316 Participants
n=107 Participants
|
759 Participants
n=206 Participants
|
7273 Participants
n=7 Participants
|
24951 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
1546 Participants
n=99 Participants
|
14710 Participants
n=107 Participants
|
1222 Participants
n=206 Participants
|
11773 Participants
n=7 Participants
|
29251 Participants
n=31 Participants
|
|
Number of participants with the indicated duration of follow-up from GPRD registration to index date
2-3 years
|
173 participants
n=99 Participants
|
1460 participants
n=107 Participants
|
129 participants
n=206 Participants
|
1081 participants
n=7 Participants
|
2843 participants
n=31 Participants
|
|
Number of participants with the indicated duration of follow-up from GPRD registration to index date
4-5 years
|
185 participants
n=99 Participants
|
1509 participants
n=107 Participants
|
117 participants
n=206 Participants
|
1135 participants
n=7 Participants
|
2946 participants
n=31 Participants
|
|
Number of participants with the indicated duration of follow-up from GPRD registration to index date
6-7 years
|
237 participants
n=99 Participants
|
2007 participants
n=107 Participants
|
141 participants
n=206 Participants
|
1280 participants
n=7 Participants
|
3665 participants
n=31 Participants
|
|
Number of participants with the indicated duration of follow-up from GPRD registration to index date
>=8 years
|
2554 participants
n=99 Participants
|
25050 participants
n=107 Participants
|
1594 participants
n=206 Participants
|
15550 participants
n=7 Participants
|
44748 participants
n=31 Participants
|
|
Number of participants with the indicated duration of follow-up from GPRD study cohort entry to ID
2-3 years
|
446 participants
n=99 Participants
|
4121 participants
n=107 Participants
|
286 participants
n=206 Participants
|
2653 participants
n=7 Participants
|
7506 participants
n=31 Participants
|
|
Number of participants with the indicated duration of follow-up from GPRD study cohort entry to ID
4-5 years
|
396 participants
n=99 Participants
|
3656 participants
n=107 Participants
|
226 participants
n=206 Participants
|
2122 participants
n=7 Participants
|
6400 participants
n=31 Participants
|
|
Number of participants with the indicated duration of follow-up from GPRD study cohort entry to ID
6-7 years
|
447 participants
n=99 Participants
|
4213 participants
n=107 Participants
|
246 participants
n=206 Participants
|
2338 participants
n=7 Participants
|
7244 participants
n=31 Participants
|
|
Number of participants with the indicated duration of follow-up from GPRD study cohort entry to ID
>=8 years
|
1860 participants
n=99 Participants
|
18036 participants
n=107 Participants
|
1223 participants
n=206 Participants
|
11933 participants
n=7 Participants
|
33052 participants
n=31 Participants
|
|
Number of participants with the indicated body mass index (BMI)
<18.5 kg/m^2
|
25 participants
n=99 Participants
|
203 participants
n=107 Participants
|
18 participants
n=206 Participants
|
110 participants
n=7 Participants
|
356 participants
n=31 Participants
|
|
Number of participants with the indicated body mass index (BMI)
18.5 to 24.99 kg/m^2
|
459 participants
n=99 Participants
|
3678 participants
n=107 Participants
|
237 participants
n=206 Participants
|
2236 participants
n=7 Participants
|
6610 participants
n=31 Participants
|
|
Number of participants with the indicated body mass index (BMI)
25 to 29.99 kg/m^2
|
457 participants
n=99 Participants
|
4250 participants
n=107 Participants
|
326 participants
n=206 Participants
|
2938 participants
n=7 Participants
|
7971 participants
n=31 Participants
|
|
Number of participants with the indicated body mass index (BMI)
>=30 kg/m^2
|
291 participants
n=99 Participants
|
2476 participants
n=107 Participants
|
250 participants
n=206 Participants
|
1773 participants
n=7 Participants
|
4790 participants
n=31 Participants
|
|
Number of participants with the indicated body mass index (BMI)
Missing
|
1917 participants
n=99 Participants
|
19419 participants
n=107 Participants
|
1150 participants
n=206 Participants
|
11989 participants
n=7 Participants
|
34475 participants
n=31 Participants
|
|
Number of participants with the indicated smoking status
Current Smoker
|
731 participants
n=99 Participants
|
4857 participants
n=107 Participants
|
476 participants
n=206 Participants
|
3555 participants
n=7 Participants
|
9619 participants
n=31 Participants
|
|
Number of participants with the indicated smoking status
Ex-smoker
|
768 participants
n=99 Participants
|
6626 participants
n=107 Participants
|
524 participants
n=206 Participants
|
4589 participants
n=7 Participants
|
12507 participants
n=31 Participants
|
|
Number of participants with the indicated smoking status
Never Smoked
|
1385 participants
n=99 Participants
|
15249 participants
n=107 Participants
|
867 participants
n=206 Participants
|
9121 participants
n=7 Participants
|
26622 participants
n=31 Participants
|
|
Number of participants with the indicated smoking status
Status Unknown
|
265 participants
n=99 Participants
|
3294 participants
n=107 Participants
|
114 participants
n=206 Participants
|
1781 participants
n=7 Participants
|
5454 participants
n=31 Participants
|
|
Number of participants with the indicated medical conditions in Pancreatic Cancer Cases/Controls
Diabetes (>=2 years prior to index date [ID])
|
363 participants
n=99 Participants
|
2137 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
2500 participants
n=31 Participants
|
|
Number of participants with the indicated medical conditions in Pancreatic Cancer Cases/Controls
Epilepsy
|
53 participants
n=99 Participants
|
458 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
511 participants
n=31 Participants
|
|
Number of participants with the indicated medical conditions in Pancreatic Cancer Cases/Controls
Neuropathic Pain
|
737 participants
n=99 Participants
|
6616 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
7353 participants
n=31 Participants
|
|
Number of participants with the indicated medical conditions in Pancreatic Cancer Cases/Controls
Chronic Pancreatitis (>=2 years prior to ID)
|
13 participants
n=99 Participants
|
17 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
30 participants
n=31 Participants
|
|
Number of participants with the indicated medical conditions/drug use in Renal Cancer Cases/Controls
Hypertension
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1159 participants
n=206 Participants
|
9113 participants
n=7 Participants
|
10272 participants
n=31 Participants
|
|
Number of participants with the indicated medical conditions/drug use in Renal Cancer Cases/Controls
Diuretic use
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
875 participants
n=206 Participants
|
6396 participants
n=7 Participants
|
7271 participants
n=31 Participants
|
|
Number of participants with the indicated medical conditions/drug use in Renal Cancer Cases/Controls
Diabetes
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
240 participants
n=206 Participants
|
1598 participants
n=7 Participants
|
1838 participants
n=31 Participants
|
|
Number of participants with the indicated medical conditions/drug use in Renal Cancer Cases/Controls
Epilepsy
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
33 participants
n=206 Participants
|
303 participants
n=7 Participants
|
336 participants
n=31 Participants
|
|
Number of participants with the indicated medical conditions/drug use in Renal Cancer Cases/Controls
Neuropathic Pain
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
428 participants
n=206 Participants
|
4018 participants
n=7 Participants
|
4446 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 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 casePopulation: 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.
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).
Outcome measures
| Measure |
Cases
n=3149 Participants
Cases
|
Controls
n=30026 Participants
Controls
|
|---|---|---|
|
Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin
Ever (without 2 year lag)
|
56 participants
|
253 participants
|
|
Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin
Never (without 2 year lag)
|
3093 participants
|
29773 participants
|
|
Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin
Ever (with 2 year lag)
|
24 participants
|
143 participants
|
|
Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin
Never (with 2 year lag)
|
3125 participants
|
29883 participants
|
PRIMARY outcome
Timeframe: 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 casePopulation: 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.
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).
Outcome measures
| Measure |
Cases
n=3149 Participants
Cases
|
Controls
n=30026 Participants
Controls
|
|---|---|---|
|
Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions
Never (without 2 year lag)
|
3093 participants
|
29773 participants
|
|
Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions
Tertile 1 (without 2 year lag)
|
30 participants
|
99 participants
|
|
Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions
Tertile 2 (without 2 year lag)
|
12 participants
|
64 participants
|
|
Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions
Tertile 3 (without 2 year lag)
|
14 participants
|
90 participants
|
|
Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions
Never (with 2 year lag)
|
3125 participants
|
29883 participants
|
|
Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions
Tertile 1 (with 2 year lag)
|
14 participants
|
48 participants
|
|
Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions
Tertile 2 (with 2 year lag)
|
3 participants
|
49 participants
|
|
Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions
Tertile 3 (with 2 year lag)
|
7 participants
|
46 participants
|
PRIMARY outcome
Timeframe: 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 casePopulation: 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.
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).
Outcome measures
| Measure |
Cases
n=3149 Participants
Cases
|
Controls
n=30026 Participants
Controls
|
|---|---|---|
|
Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin
Never (without 2 year lag)
|
3093 participants
|
29773 participants
|
|
Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin
Tertile 1 (without 2 year lag)
|
28 participants
|
83 participants
|
|
Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin
Tertile 2 (without 2 year lag)
|
14 participants
|
79 participants
|
|
Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin
Tertile 3 (without 2 year lag)
|
14 participants
|
91 participants
|
|
Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin
Never (with 2 year lag)
|
3125 participants
|
29883 participants
|
|
Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin
Tertile 1 (with 2 year lag)
|
13 participants
|
44 participants
|
|
Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin
Tertile 2 (with 2 year lag)
|
4 participants
|
47 participants
|
|
Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin
Tertile 3 (with 2 year lag)
|
7 participants
|
52 participants
|
PRIMARY outcome
Timeframe: 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 casePopulation: 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.
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).
Outcome measures
| Measure |
Cases
n=3149 Participants
Cases
|
Controls
n=30026 Participants
Controls
|
|---|---|---|
|
Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin
Never (without 2 year lag)
|
3093 participants
|
29773 participants
|
|
Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin
Tertile 1 (without 2 year lag)
|
28 participants
|
88 participants
|
|
Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin
Tertile 2 (without 2 year lag)
|
14 participants
|
74 participants
|
|
Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin
Tertile 3 (without 2 year lag)
|
14 participants
|
91 participants
|
|
Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin
Never (with 2 year lag)
|
3125 participants
|
29883 participants
|
|
Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin
Tertile 1 (with 2 year lag)
|
11 participants
|
46 participants
|
|
Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin
Tertile 2 (with 2 year lag)
|
7 participants
|
47 participants
|
|
Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin
Tertile 3 (with 2 year lag)
|
6 participants
|
50 participants
|
PRIMARY outcome
Timeframe: 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.Population: 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.
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).
Outcome measures
| Measure |
Cases
n=1981 Participants
Cases
|
Controls
n=19046 Participants
Controls
|
|---|---|---|
|
Number of Renal Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin
Never (with 2 year lag)
|
1968 participants
|
18970 participants
|
|
Number of Renal Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin
Ever (without 2 year lag)
|
32 participants
|
166 participants
|
|
Number of Renal Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin
Never (without 2 year lag)
|
1949 participants
|
18880 participants
|
|
Number of Renal Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin
Ever (with 2 year lag)
|
13 participants
|
76 participants
|
PRIMARY outcome
Timeframe: 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.Population: 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.
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).
Outcome measures
| Measure |
Cases
n=1981 Participants
Cases
|
Controls
n=19046 Participants
Controls
|
|---|---|---|
|
Number of Renal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions
Never (without 2 year lag)
|
1949 participants
|
18880 participants
|
|
Number of Renal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions
Tertile 1 (without 2 year lag)
|
16 participants
|
58 participants
|
|
Number of Renal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions
Tertile 2 (without 2 year lag)
|
11 participants
|
55 participants
|
|
Number of Renal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions
Tertile 3 (without 2 year lag)
|
5 participants
|
53 participants
|
|
Number of Renal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions
Never (with 2 year lag)
|
1968 participants
|
18970 participants
|
|
Number of Renal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions
Tertile 1 (with 2 year lag)
|
6 participants
|
27 participants
|
|
Number of Renal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions
Tertile 2 (with 2 year lag)
|
4 participants
|
28 participants
|
|
Number of Renal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions
Tertile 3 (with 2 year lag)
|
3 participants
|
21 participants
|
PRIMARY outcome
Timeframe: 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.Population: 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.
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).
Outcome measures
| Measure |
Cases
n=1981 Participants
Cases
|
Controls
n=19046 Participants
Controls
|
|---|---|---|
|
Number of Renal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin
Never (without 2 year lag)
|
1949 participants
|
18880 participants
|
|
Number of Renal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin
Tertile 1 (without 2 year lag)
|
15 participants
|
44 participants
|
|
Number of Renal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin
Tertile 2 (without 2 year lag)
|
10 participants
|
67 participants
|
|
Number of Renal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin
Tertile 3 (without 2 year lag)
|
7 participants
|
55 participants
|
|
Number of Renal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin
Never (with 2 year lag)
|
1968 participants
|
18970 participants
|
|
Number of Renal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin
Tertile 1 (with 2 year lag)
|
6 participants
|
23 participants
|
|
Number of Renal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin
Tertile 2 (with 2 year lag)
|
3 participants
|
31 participants
|
|
Number of Renal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin
Tertile 3 (with 2 year lag)
|
4 participants
|
22 participants
|
PRIMARY outcome
Timeframe: 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.Population: 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.
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).
Outcome measures
| Measure |
Cases
n=1981 Participants
Cases
|
Controls
n=19046 Participants
Controls
|
|---|---|---|
|
Number of Renal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin
Never (without 2 year lag)
|
1949 participants
|
18880 participants
|
|
Number of Renal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin
Tertile 1 (without 2 year lag)
|
9 participants
|
45 participants
|
|
Number of Renal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin
Tertile 2 (without 2 year lag)
|
17 participants
|
63 participants
|
|
Number of Renal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin
Tertile 3 (without 2 year lag)
|
6 participants
|
58 participants
|
|
Number of Renal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin
Never (with 2 year lag)
|
1968 participants
|
18970 participants
|
|
Number of Renal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin
Tertile 1 (with 2 year lag)
|
5 participants
|
24 participants
|
|
Number of Renal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin
Tertile 2 (with 2 year lag)
|
5 participants
|
26 participants
|
|
Number of Renal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin
Tertile 3 (with 2 year lag)
|
3 participants
|
26 participants
|
Adverse Events
Pancreatic Cancer Cases
Pancreatic Cancer Controls
Renal Cancer Cases
Renal Cancer Controls
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER