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NCT01236053 · OUTCOME

Number of Renal Cancer Cases and Matched Controls With the Indicated 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 pancreatic 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 for the case.

What was measured

Incident renal cancer. Gabapentin Exposure Description: 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). Without 2 year lag = Gabapentin prescription 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 Renal Cancer Patients

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

Matched Controls for Incident Renal Cancer Patients

Cancer-free control patients risk set matched with incident renal 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 Renal Cancer Patients1272
Matched Controls for Incident Renal Cancer Patients12167

Reported measurements

Ever (with 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Incident Renal Cancer Patients9Not reportedNot reportedNot reportedNot reported
Matched Controls for Incident Renal Cancer Patients53Not reportedNot reportedNot reportedNot reported
Never (with 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Incident Renal Cancer Patients1263Not reportedNot reportedNot reportedNot reported
Matched Controls for Incident Renal Cancer Patients12114Not reportedNot reportedNot reportedNot reported
Ever (without 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Incident Renal Cancer Patients15Not reportedNot reportedNot reportedNot reported
Matched Controls for Incident Renal Cancer Patients107Not reportedNot reportedNot reportedNot reported
Never (without 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Incident Renal Cancer Patients1257Not reportedNot reportedNot reportedNot reported
Matched Controls for Incident Renal Cancer Patients12060Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.80
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    3.34
    estimate Comment
    Comparison: "Ever (with 2 year lag)" and "Never (with 2 year lag)".
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.1757
    param Type
    Odds Ratio (OR)
    param Value
    1.64
    statistical Method
    Conditional Logistic Regression
  2. ci Lower Limit
    0.64
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.75
    estimate Comment
    Comparison: "Ever (with 2 year lag)" and "Never (with 2 year lag)". Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.4405
    param Type
    Odds Ratio (OR)
    param Value
    1.33
    statistical Method
    Conditional Logistic Regression
  3. ci Lower Limit
    0.71
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.16
    estimate Comment
    Comparison: "Ever (without 2 year lag)" and "Never (without 2 year lag)".
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.4420
    param Type
    Odds Ratio (OR)
    param Value
    1.24
    statistical Method
    Conditional Logistic Regression
  4. ci Lower Limit
    0.59
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.82
    estimate Comment
    Comparison: "Ever (without 2 year lag)" and "Never (without 2 year lag)". Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.9034
    param Type
    Odds Ratio (OR)
    param Value
    1.04
    statistical Method
    Conditional Logistic Regression
Complete source fields
analyses
  1. ci Lower Limit
    0.80
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    3.34
    estimate Comment
    Comparison: "Ever (with 2 year lag)" and "Never (with 2 year lag)".
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.1757
    param Type
    Odds Ratio (OR)
    param Value
    1.64
    statistical Method
    Conditional Logistic Regression
  2. ci Lower Limit
    0.64
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.75
    estimate Comment
    Comparison: "Ever (with 2 year lag)" and "Never (with 2 year lag)". Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.4405
    param Type
    Odds Ratio (OR)
    param Value
    1.33
    statistical Method
    Conditional Logistic Regression
  3. ci Lower Limit
    0.71
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.16
    estimate Comment
    Comparison: "Ever (without 2 year lag)" and "Never (without 2 year lag)".
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.4420
    param Type
    Odds Ratio (OR)
    param Value
    1.24
    statistical Method
    Conditional Logistic Regression
  4. ci Lower Limit
    0.59
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.82
    estimate Comment
    Comparison: "Ever (without 2 year lag)" and "Never (without 2 year lag)". Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.9034
    param Type
    Odds Ratio (OR)
    param Value
    1.04
    statistical Method
    Conditional Logistic Regression
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        53
    title
    Ever (with 2 year lag)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1263
      2. group Id
        OG001
        value
        12114
    title
    Never (with 2 year lag)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        107
    title
    Ever (without 2 year lag)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1257
      2. group Id
        OG001
        value
        12060
    title
    Never (without 2 year lag)
denoms
  1. counts
    1. group Id
      OG000
      value
      1272
    2. group Id
      OG001
      value
      12167
    units
    Participants
description
Incident renal cancer. Gabapentin Exposure Description: 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). Without 2 year lag = Gabapentin prescription from cohort entry to index date.
groups
  1. description
    Patients with incident renal cancer defined from READ/OXMIS codes in the years 1995-2008
    id
    OG000
    title
    Incident Renal Cancer Patients
  2. description
    Cancer-free control patients risk set matched with incident renal 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 Renal 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 pancreatic 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 for the case.
title
Number of Renal Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin
type
PRIMARY
unit Of Measure
participants

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Preserved source evidence · Not medical advice