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NCT01236053 · OUTCOME

Number of Bladder Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin

Cancer in Patients With Gabapentin (GPRD) · Source last updated 2017-07-06

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
The case index date was the date of incident bladder 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

What was measured

Incident bladder cancer. Gabapentin Exposure Description: 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). Without 2 year lag = Gabapentin exposure from cohort entry to index date.

Analysis population: Cases \& controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.

Groups in this outcome

Incident Bladder Cancer Patients

Patients with incident bladder cancer defined from READ/OXMIS codes in the years 1995-2008

Matched Controls for Incident Bladder Cancer Patients

Cancer-free control patients risk set matched with incident bladder cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Incident Bladder Cancer Patients4600
Matched Controls for Incident Bladder Cancer Patients43559

Reported measurements

Never (with 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Incident Bladder Cancer Patients4585Not reportedNot reportedNot reportedNot reported
Matched Controls for Incident Bladder Cancer Patients43415Not reportedNot reportedNot reportedNot reported
> 1 year (with 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Incident Bladder Cancer Patients2Not reportedNot reportedNot reportedNot reported
Matched Controls for Incident Bladder Cancer Patients21Not reportedNot reportedNot reportedNot reported
> 2 year (with 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Incident Bladder Cancer Patients0Not reportedNot reportedNot reportedNot reported
Matched Controls for Incident Bladder Cancer Patients7Not reportedNot reportedNot reportedNot reported
> 3 year (with 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Incident Bladder Cancer Patients0Not reportedNot reportedNot reportedNot reported
Matched Controls for Incident Bladder Cancer Patients3Not reportedNot reportedNot reportedNot reported
Never (without 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Incident Bladder Cancer Patients4567Not reportedNot reportedNot reportedNot reported
Matched Controls for Incident Bladder Cancer Patients43260Not reportedNot reportedNot reportedNot reported
> 1 year (without 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Incident Bladder Cancer Patients6Not reportedNot reportedNot reportedNot reported
Matched Controls for Incident Bladder Cancer Patients52Not reportedNot reportedNot reportedNot reported
> 2 year (without 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Incident Bladder Cancer Patients2Not reportedNot reportedNot reportedNot reported
Matched Controls for Incident Bladder Cancer Patients24Not reportedNot reportedNot reportedNot reported
> 3 year (without 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Incident Bladder Cancer Patients1Not reportedNot reportedNot reportedNot reported
Matched Controls for Incident Bladder Cancer Patients10Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4585
      2. group Id
        OG001
        value
        43415
    title
    Never (with 2 year lag)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        21
    title
    > 1 year (with 2 year lag)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        7
    title
    > 2 year (with 2 year lag)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        3
    title
    > 3 year (with 2 year lag)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        4567
      2. group Id
        OG001
        value
        43260
    title
    Never (without 2 year lag)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        52
    title
    > 1 year (without 2 year lag)
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        24
    title
    > 2 year (without 2 year lag)
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        10
    title
    > 3 year (without 2 year lag)
denoms
  1. counts
    1. group Id
      OG000
      value
      4600
    2. group Id
      OG001
      value
      43559
    units
    Participants
description
Incident bladder cancer. Gabapentin Exposure Description: 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). Without 2 year lag = Gabapentin exposure from cohort entry to index date.
groups
  1. description
    Patients with incident bladder cancer defined from READ/OXMIS codes in the years 1995-2008
    id
    OG000
    title
    Incident Bladder Cancer Patients
  2. description
    Cancer-free control patients risk set matched with incident bladder cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
    id
    OG001
    title
    Matched Controls for Incident Bladder Cancer Patients
param Type
NUMBER
population Description
Cases \& controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.
reporting Status
POSTED
time Frame
The case index date was the date of incident bladder 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
title
Number of Bladder Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin
type
PRIMARY
unit Of Measure
participants

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Preserved source evidence · Not medical advice