Risk of Cancer in Patients Exposed to Gabapentin in the GPRD
N/A
N/A
Both
Pain, Neuropathic, Epilepsy, Renal Pelvis Cancer, Pancreatic Cancer, Breast Cancer, Nervous System Cancer, Chronic Pancreatitis, Stomach Cancer, Renal Cell Carcinoma, Diabetes, Bladder Cancer, Bone and Joint Cancer, Penis Cancer, Anal Cancer, Cancer, Renal Cancer
Trial Information
Risk of Cancer in Patients Exposed to Gabapentin in the GPRD
Actual number of patients may be less, as it is possible for a patient to be represented in
more than one of the 22 arms (See "Participant Flow: Overall Study" Table) because of the
risk set sampling.
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 subject leaves the GPRD
for any reason including death.
Exclusion Criteria:
- Subjects are excluded from the GPRD cohort if they have a cancer diagnosis or a
history of cancer prior to the cohort entry date. 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.) Cases must have no history of any other
cancer diagnosis prior to the index date. Controls are required to be free of
cancer diagnosis in the database up to the control's index date.
Type of Study:
Observational
Study Design:
Observational Model: Case Control, Time Perspective: Retrospective
Outcome Measure:
Number of All-Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin
Outcome Description:
Incidence of all cancers. 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 Time Frame:
The case index date was the date of incident cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.
Safety Issue:
Yes
Principal Investigator
GSK Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
GlaxoSmithKline
Authority:
United States: No Health Authority
Study ID:
114790
NCT ID:
NCT01236053
Start Date:
June 2010
Completion Date:
September 2010
Related Keywords:
- Pain, Neuropathic
- Epilepsy
- Renal Pelvis Cancer
- Pancreatic Cancer
- Breast Cancer
- Nervous System Cancer
- Chronic Pancreatitis
- Stomach Cancer
- Renal Cell Carcinoma
- Diabetes
- Bladder Cancer
- Bone and Joint Cancer
- Penis Cancer
- Anal Cancer
- Cancer
- Renal Cancer
- renal cancer
- pancreatic cancer
- epidemiology
- renal cell carcinoma
- nervous system cancer
- lung cancer
- breast cancer
- case-control
- GPRD
- Gapabentin
- cancer
- anal cancer
- bone and joint cancer
- renal pelvis cancer
- penis cancer
- stomach cancer
- bladder cancer
- Anus Neoplasms
- Urinary Bladder Neoplasms
- Breast Neoplasms
- Carcinoma
- Carcinoma, Renal Cell
- Kidney Neoplasms
- Epilepsy
- Stomach Neoplasms
- Nervous System Neoplasms
- Neuralgia
- Pancreatic Neoplasms
- Pancreatitis
- Pancreatitis, Chronic
- Penile Neoplasms
- Pelvic Neoplasms
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