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NCT01236053 · OUTCOME

Number of All-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 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

Incidence of all cancers. 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 All-cancer Patients

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

Matched Controls for Incident All-cancer Patients

Cancer-free control patients risk set matched with incident all-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 All-cancer Patients179138
Matched Controls for Incident All-cancer Patients1710950

Reported measurements

Never (with 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Incident All-cancer Patients178334Not reportedNot reportedNot reportedNot reported
Matched Controls for Incident All-cancer Patients1704443Not reportedNot reportedNot reportedNot reported
> 1 year (with 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Incident All-cancer Patients157Not reportedNot reportedNot reportedNot reported
Matched Controls for Incident All-cancer Patients1217Not reportedNot reportedNot reportedNot reported
> 2 year (with 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Incident All-cancer Patients64Not reportedNot reportedNot reportedNot reported
Matched Controls for Incident All-cancer Patients463Not reportedNot reportedNot reportedNot reported
> 3 year (with 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Incident All-cancer Patients25Not reportedNot reportedNot reportedNot reported
Matched Controls for Incident All-cancer Patients197Not reportedNot reportedNot reportedNot reported
Never (without 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Incident All-cancer Patients177409Not reportedNot reportedNot reportedNot reported
Matched Controls for Incident All-cancer Patients1698480Not reportedNot reportedNot reportedNot reported
> 1 year (without 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Incident All-cancer Patients301Not reportedNot reportedNot reportedNot reported
Matched Controls for Incident All-cancer Patients2499Not reportedNot reportedNot reportedNot reported
> 2 year (without 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Incident All-cancer Patients159Not reportedNot reportedNot reportedNot reported
Matched Controls for Incident All-cancer Patients1207Not reportedNot reportedNot reportedNot reported
> 3 year (without 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Incident All-cancer Patients76Not reportedNot reportedNot reportedNot reported
Matched Controls for Incident All-cancer Patients549Not 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
    1.01
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.41
    estimate Comment
    Comparison: "\> 1 year (with 2 year lag)" and "Never (with 2 year lag)".
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0369
    param Type
    Odds Ratio (OR)
    param Value
    1.20
    statistical Method
    Conditional Logistic Regression
  2. ci Lower Limit
    0.92
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.29
    estimate Comment
    Comparison: "\> 1 year (with 2 year lag)" and "Never (with 2 year lag)". Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.3132
    param Type
    Odds Ratio (OR)
    param Value
    1.09
    statistical Method
    Conditional Logistic Regression
  3. ci Lower Limit
    0.99
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.26
    estimate Comment
    Comparison: "\> 1 year (without 2 year lag)" and "Never (without 2 year lag)".
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0762
    param Type
    Odds Ratio (OR)
    param Value
    1.12
    statistical Method
    Conditional Logistic Regression
  4. ci Lower Limit
    0.91
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.15
    estimate Comment
    Comparison: "\> 1 year (without 2 year lag)" and "Never (without 2 year lag)". Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.7243
    param Type
    Odds Ratio (OR)
    param Value
    1.02
    statistical Method
    Conditional Logistic Regression
  5. ci Lower Limit
    0.97
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.65
    estimate Comment
    Comparison: "\> 2 years (with 2 year lag)" and "Never (with 2 year lag)".
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0775
    param Type
    Odds Ratio (OR)
    param Value
    1.27
    statistical Method
    Conditional Logistic Regression
  6. ci Lower Limit
    0.89
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.52
    estimate Comment
    Comparison: "\> 2 years (with 2 year lag)" and "Never (with 2 year lag)". Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.2649
    param Type
    Odds Ratio (OR)
    param Value
    1.16
    statistical Method
    Conditional Logistic Regression
  7. ci Lower Limit
    1.02
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.43
    estimate Comment
    Comparison: "\> 2 years (without 2 year lag)" and "Never (without 2 year lag)".
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0257
    param Type
    Odds Ratio (OR)
    param Value
    1.21
    statistical Method
    Conditional Logistic Regression
  8. ci Lower Limit
    0.93
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.30
    estimate Comment
    Comparison: "\> 2 years (without 2 year lag)" and "Never (without 2 year lag)". Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.2540
    param Type
    Odds Ratio (OR)
    param Value
    1.10
    statistical Method
    Conditional Logistic Regression
  9. ci Lower Limit
    0.76
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.75
    estimate Comment
    Comparison: "\> 3 years (with 2 year lag)" and "Never (with 2 year lag)".
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.5141
    param Type
    Odds Ratio (OR)
    param Value
    1.15
    statistical Method
    Conditional Logistic Regression
  10. ci Lower Limit
    0.69
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.60
    estimate Comment
    Comparison: "\> 3 years (with 2 year lag)" and "Never (with 2 year lag)". Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.8208
    param Type
    Odds Ratio (OR)
    param Value
    1.05
    statistical Method
    Conditional Logistic Regression
  11. ci Lower Limit
    0.99
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.62
    estimate Comment
    Comparison: "\> 3 years (without 2 year lag)" and "Never (without 2 year lag)".
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0562
    param Type
    Odds Ratio (OR)
    param Value
    1.27
    statistical Method
    Conditional Logistic Regression
  12. ci Lower Limit
    0.90
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.47
    estimate Comment
    Comparison: "\> 3 years (without 2 year lag)" and "Never (without 2 year lag)". Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.2596
    param Type
    Odds Ratio (OR)
    param Value
    1.15
    statistical Method
    Conditional Logistic Regression
Complete source fields
analyses
  1. ci Lower Limit
    1.01
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.41
    estimate Comment
    Comparison: "\> 1 year (with 2 year lag)" and "Never (with 2 year lag)".
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0369
    param Type
    Odds Ratio (OR)
    param Value
    1.20
    statistical Method
    Conditional Logistic Regression
  2. ci Lower Limit
    0.92
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.29
    estimate Comment
    Comparison: "\> 1 year (with 2 year lag)" and "Never (with 2 year lag)". Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.3132
    param Type
    Odds Ratio (OR)
    param Value
    1.09
    statistical Method
    Conditional Logistic Regression
  3. ci Lower Limit
    0.99
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.26
    estimate Comment
    Comparison: "\> 1 year (without 2 year lag)" and "Never (without 2 year lag)".
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0762
    param Type
    Odds Ratio (OR)
    param Value
    1.12
    statistical Method
    Conditional Logistic Regression
  4. ci Lower Limit
    0.91
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.15
    estimate Comment
    Comparison: "\> 1 year (without 2 year lag)" and "Never (without 2 year lag)". Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.7243
    param Type
    Odds Ratio (OR)
    param Value
    1.02
    statistical Method
    Conditional Logistic Regression
  5. ci Lower Limit
    0.97
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.65
    estimate Comment
    Comparison: "\> 2 years (with 2 year lag)" and "Never (with 2 year lag)".
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0775
    param Type
    Odds Ratio (OR)
    param Value
    1.27
    statistical Method
    Conditional Logistic Regression
  6. ci Lower Limit
    0.89
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.52
    estimate Comment
    Comparison: "\> 2 years (with 2 year lag)" and "Never (with 2 year lag)". Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.2649
    param Type
    Odds Ratio (OR)
    param Value
    1.16
    statistical Method
    Conditional Logistic Regression
  7. ci Lower Limit
    1.02
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.43
    estimate Comment
    Comparison: "\> 2 years (without 2 year lag)" and "Never (without 2 year lag)".
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0257
    param Type
    Odds Ratio (OR)
    param Value
    1.21
    statistical Method
    Conditional Logistic Regression
  8. ci Lower Limit
    0.93
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.30
    estimate Comment
    Comparison: "\> 2 years (without 2 year lag)" and "Never (without 2 year lag)". Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.2540
    param Type
    Odds Ratio (OR)
    param Value
    1.10
    statistical Method
    Conditional Logistic Regression
  9. ci Lower Limit
    0.76
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.75
    estimate Comment
    Comparison: "\> 3 years (with 2 year lag)" and "Never (with 2 year lag)".
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.5141
    param Type
    Odds Ratio (OR)
    param Value
    1.15
    statistical Method
    Conditional Logistic Regression
  10. ci Lower Limit
    0.69
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.60
    estimate Comment
    Comparison: "\> 3 years (with 2 year lag)" and "Never (with 2 year lag)". Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.8208
    param Type
    Odds Ratio (OR)
    param Value
    1.05
    statistical Method
    Conditional Logistic Regression
  11. ci Lower Limit
    0.99
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.62
    estimate Comment
    Comparison: "\> 3 years (without 2 year lag)" and "Never (without 2 year lag)".
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0562
    param Type
    Odds Ratio (OR)
    param Value
    1.27
    statistical Method
    Conditional Logistic Regression
  12. ci Lower Limit
    0.90
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.47
    estimate Comment
    Comparison: "\> 3 years (without 2 year lag)" and "Never (without 2 year lag)". Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.2596
    param Type
    Odds Ratio (OR)
    param Value
    1.15
    statistical Method
    Conditional Logistic Regression
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        178334
      2. group Id
        OG001
        value
        1704443
    title
    Never (with 2 year lag)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        157
      2. group Id
        OG001
        value
        1217
    title
    > 1 year (with 2 year lag)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        64
      2. group Id
        OG001
        value
        463
    title
    > 2 year (with 2 year lag)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        25
      2. group Id
        OG001
        value
        197
    title
    > 3 year (with 2 year lag)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        177409
      2. group Id
        OG001
        value
        1698480
    title
    Never (without 2 year lag)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        301
      2. group Id
        OG001
        value
        2499
    title
    > 1 year (without 2 year lag)
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        159
      2. group Id
        OG001
        value
        1207
    title
    > 2 year (without 2 year lag)
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        76
      2. group Id
        OG001
        value
        549
    title
    > 3 year (without 2 year lag)
denoms
  1. counts
    1. group Id
      OG000
      value
      179138
    2. group Id
      OG001
      value
      1710950
    units
    Participants
description
Incidence of all cancers. 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 any type of incident cancer defined from READ/OXMIS codes in the years 1995-2008
    id
    OG000
    title
    Incident All-cancer Patients
  2. description
    Cancer-free control patients risk set matched with incident all-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 All-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 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 All-Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin
type
PRIMARY
unit Of Measure
participants

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