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NCT01236053 · OUTCOME

Number of All-Cancer Cases and Matched Controls With the Indicated Cumulative Dose of 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. Tertile's with 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 9600.0 grams). Tertile's without 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 11610.0 grams).

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
Tertile 1 (with 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Incident All-cancer Patients269Not reportedNot reportedNot reportedNot reported
Matched Controls for Incident All-cancer Patients2222Not reportedNot reportedNot reportedNot reported
Tertile 2 (with 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Incident All-cancer Patients268Not reportedNot reportedNot reportedNot reported
Matched Controls for Incident All-cancer Patients2118Not reportedNot reportedNot reportedNot reported
Tertile 3 (with 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Incident All-cancer Patients267Not reportedNot reportedNot reportedNot reported
Matched Controls for Incident All-cancer Patients2167Not 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
Tertile 1 (without 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Incident All-cancer Patients640Not reportedNot reportedNot reportedNot reported
Matched Controls for Incident All-cancer Patients4438Not reportedNot reportedNot reportedNot reported
Tertile 2 (without 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Incident All-cancer Patients585Not reportedNot reportedNot reportedNot reported
Matched Controls for Incident All-cancer Patients3882Not reportedNot reportedNot reportedNot reported
Tertile 3 (without 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Incident All-cancer Patients504Not reportedNot reportedNot reportedNot reported
Matched Controls for Incident All-cancer Patients4150Not 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
    0.99
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.28
    estimate Comment
    Comparison: "Tertile 1 (with 2 year lag)" and "Never (with 2 year lag)".
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0709
    param Type
    Odds Ratio (OR)
    param Value
    1.12
    statistical Method
    Conditional Logistic Regression
  2. ci Lower Limit
    0.92
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.19
    estimate Comment
    Comparison: "Tertile 1 (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
    0.4996
    param Type
    Odds Ratio (OR)
    param Value
    1.05
    statistical Method
    Conditional Logistic Regression
  3. ci Lower Limit
    1.23
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.45
    estimate Comment
    Comparison: "Tertile 1 (without 2 year lag)" and "Never (without 2 year lag)".
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    param Type
    Odds Ratio (OR)
    param Value
    1.34
    statistical Method
    Conditional Logistic Regression
  4. ci Lower Limit
    1.14
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.35
    estimate Comment
    Comparison: "Tertile 1 (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
    <0.0001
    param Type
    Odds Ratio (OR)
    param Value
    1.24
    statistical Method
    Conditional Logistic Regression
  5. ci Lower Limit
    1.05
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.36
    estimate Comment
    Comparison: "Tertile 2 (with 2 year lag)" and "Never (with 2 year lag)".
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0062
    param Type
    Odds Ratio (OR)
    param Value
    1.20
    statistical Method
    Conditional Logistic Regression
  6. ci Lower Limit
    0.98
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.26
    estimate Comment
    Comparison: "Tertile 2 (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
    0.1144
    param Type
    Odds Ratio (OR)
    param Value
    1.11
    statistical Method
    Conditional Logistic Regression
  7. ci Lower Limit
    1.30
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.55
    estimate Comment
    Comparison: "Tertile 2 (without 2 year lag)" and "Never (without 2 year lag)".
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    param Type
    Odds Ratio (OR)
    param Value
    1.42
    statistical Method
    Conditional Logistic Regression
  8. ci Lower Limit
    1.20
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.43
    estimate Comment
    Comparison: "Tertile 2 (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
    <0.0001
    param Type
    Odds Ratio (OR)
    param Value
    1.31
    statistical Method
    Conditional Logistic Regression
  9. ci Lower Limit
    1.00
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.29
    estimate Comment
    Comparison: "Tertile 3 (with 2 year lag)" and "Never (with 2 year lag)".
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0469
    param Type
    Odds Ratio (OR)
    param Value
    1.14
    statistical Method
    Conditional Logistic Regression
  10. ci Lower Limit
    0.92
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.19
    estimate Comment
    Comparison: "Tertile 3 (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
    0.5169
    param Type
    Odds Ratio (OR)
    param Value
    1.04
    statistical Method
    Conditional Logistic Regression
  11. ci Lower Limit
    1.03
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.24
    estimate Comment
    Comparison: "Tertile 3 (without 2 year lag)" and "Never (without 2 year lag)".
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0103
    param Type
    Odds Ratio (OR)
    param Value
    1.13
    statistical Method
    Conditional Logistic Regression
  12. ci Lower Limit
    0.95
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.14
    estimate Comment
    Comparison: "Tertile 3 (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
    0.4182
    param Type
    Odds Ratio (OR)
    param Value
    1.04
    statistical Method
    Conditional Logistic Regression
Complete source fields
analyses
  1. ci Lower Limit
    0.99
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.28
    estimate Comment
    Comparison: "Tertile 1 (with 2 year lag)" and "Never (with 2 year lag)".
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0709
    param Type
    Odds Ratio (OR)
    param Value
    1.12
    statistical Method
    Conditional Logistic Regression
  2. ci Lower Limit
    0.92
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.19
    estimate Comment
    Comparison: "Tertile 1 (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
    0.4996
    param Type
    Odds Ratio (OR)
    param Value
    1.05
    statistical Method
    Conditional Logistic Regression
  3. ci Lower Limit
    1.23
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.45
    estimate Comment
    Comparison: "Tertile 1 (without 2 year lag)" and "Never (without 2 year lag)".
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    param Type
    Odds Ratio (OR)
    param Value
    1.34
    statistical Method
    Conditional Logistic Regression
  4. ci Lower Limit
    1.14
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.35
    estimate Comment
    Comparison: "Tertile 1 (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
    <0.0001
    param Type
    Odds Ratio (OR)
    param Value
    1.24
    statistical Method
    Conditional Logistic Regression
  5. ci Lower Limit
    1.05
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.36
    estimate Comment
    Comparison: "Tertile 2 (with 2 year lag)" and "Never (with 2 year lag)".
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0062
    param Type
    Odds Ratio (OR)
    param Value
    1.20
    statistical Method
    Conditional Logistic Regression
  6. ci Lower Limit
    0.98
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.26
    estimate Comment
    Comparison: "Tertile 2 (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
    0.1144
    param Type
    Odds Ratio (OR)
    param Value
    1.11
    statistical Method
    Conditional Logistic Regression
  7. ci Lower Limit
    1.30
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.55
    estimate Comment
    Comparison: "Tertile 2 (without 2 year lag)" and "Never (without 2 year lag)".
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    param Type
    Odds Ratio (OR)
    param Value
    1.42
    statistical Method
    Conditional Logistic Regression
  8. ci Lower Limit
    1.20
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.43
    estimate Comment
    Comparison: "Tertile 2 (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
    <0.0001
    param Type
    Odds Ratio (OR)
    param Value
    1.31
    statistical Method
    Conditional Logistic Regression
  9. ci Lower Limit
    1.00
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.29
    estimate Comment
    Comparison: "Tertile 3 (with 2 year lag)" and "Never (with 2 year lag)".
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0469
    param Type
    Odds Ratio (OR)
    param Value
    1.14
    statistical Method
    Conditional Logistic Regression
  10. ci Lower Limit
    0.92
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.19
    estimate Comment
    Comparison: "Tertile 3 (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
    0.5169
    param Type
    Odds Ratio (OR)
    param Value
    1.04
    statistical Method
    Conditional Logistic Regression
  11. ci Lower Limit
    1.03
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.24
    estimate Comment
    Comparison: "Tertile 3 (without 2 year lag)" and "Never (without 2 year lag)".
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0103
    param Type
    Odds Ratio (OR)
    param Value
    1.13
    statistical Method
    Conditional Logistic Regression
  12. ci Lower Limit
    0.95
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.14
    estimate Comment
    Comparison: "Tertile 3 (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
    0.4182
    param Type
    Odds Ratio (OR)
    param Value
    1.04
    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
        269
      2. group Id
        OG001
        value
        2222
    title
    Tertile 1 (with 2 year lag)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        268
      2. group Id
        OG001
        value
        2118
    title
    Tertile 2 (with 2 year lag)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        267
      2. group Id
        OG001
        value
        2167
    title
    Tertile 3 (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
        640
      2. group Id
        OG001
        value
        4438
    title
    Tertile 1 (without 2 year lag)
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        585
      2. group Id
        OG001
        value
        3882
    title
    Tertile 2 (without 2 year lag)
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        504
      2. group Id
        OG001
        value
        4150
    title
    Tertile 3 (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. Tertile's with 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 9600.0 grams). Tertile's without 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 11610.0 grams).
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 Cumulative Dose of Gabapentin
type
PRIMARY
unit Of Measure
participants

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