Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01236053 · OUTCOME

Number of Breast Cancer Cases and Matched Controls With the Indicated 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 breast 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 breast 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. Tertile's with 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.56 months), and Tertile 3 (5.57 - 105.82 months). Tertile's without 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.72 months), and Tertile 3 (5.73 - 123.70 months).

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 Breast Cancer Patients

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

Matched Controls for Incident Breast Cancer Patients

Cancer-free control patients risk set matched with incident breast 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 Breast Cancer Patients19564
Matched Controls for Incident Breast Cancer Patients188924

Reported measurements

Never (with 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Incident Breast Cancer Patients19468Not reportedNot reportedNot reportedNot reported
Matched Controls for Incident Breast Cancer Patients188199Not reportedNot reportedNot reportedNot reported
Tertile 1 (with 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Incident Breast Cancer Patients29Not reportedNot reportedNot reportedNot reported
Matched Controls for Incident Breast Cancer Patients245Not reportedNot reportedNot reportedNot reported
Tertile 2 (with 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Incident Breast Cancer Patients32Not reportedNot reportedNot reportedNot reported
Matched Controls for Incident Breast Cancer Patients247Not reportedNot reportedNot reportedNot reported
Tertile 3 (with 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Incident Breast Cancer Patients35Not reportedNot reportedNot reportedNot reported
Matched Controls for Incident Breast Cancer Patients233Not reportedNot reportedNot reportedNot reported
Never (without 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Incident Breast Cancer Patients19390Not reportedNot reportedNot reportedNot reported
Matched Controls for Incident Breast Cancer Patients187532Not reportedNot reportedNot reportedNot reported
Tertile 1 (without 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Incident Breast Cancer Patients58Not reportedNot reportedNot reportedNot reported
Matched Controls for Incident Breast Cancer Patients465Not reportedNot reportedNot reportedNot reported
Tertile 2 (without 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Incident Breast Cancer Patients52Not reportedNot reportedNot reportedNot reported
Matched Controls for Incident Breast Cancer Patients473Not reportedNot reportedNot reportedNot reported
Tertile 3 (without 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Incident Breast Cancer Patients64Not reportedNot reportedNot reportedNot reported
Matched Controls for Incident Breast Cancer Patients454Not 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
    0.77
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.68
    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
    0.5043
    param Type
    Odds Ratio (OR)
    param Value
    1.14
    statistical Method
    Conditional Logistic Regression
  2. ci Lower Limit
    0.73
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.59
    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, hysterectomy, current estrogen, prior estrogen, benign breast disease.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.7129
    param Type
    Odds Ratio (OR)
    param Value
    1.08
    statistical Method
    Conditional Logistic Regression
  3. ci Lower Limit
    0.91
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.57
    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
    0.2055
    param Type
    Odds Ratio (OR)
    param Value
    1.19
    statistical Method
    Conditional Logistic Regression
  4. ci Lower Limit
    0.88
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.52
    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, hysterectomy, current estrogen, prior estrogen, benign breast disease.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.3005
    param Type
    Odds Ratio (OR)
    param Value
    1.16
    statistical Method
    Conditional Logistic Regression
  5. ci Lower Limit
    0.84
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.77
    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
    0.2849
    param Type
    Odds Ratio (OR)
    param Value
    1.22
    statistical Method
    Conditional Logistic Regression
  6. ci Lower Limit
    0.82
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.72
    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, hysterectomy, current estrogen, prior estrogen, benign breast disease.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.3650
    param Type
    Odds Ratio (OR)
    param Value
    1.19
    statistical Method
    Conditional Logistic Regression
  7. ci Lower Limit
    0.78
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.40
    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
    0.7559
    param Type
    Odds Ratio (OR)
    param Value
    1.05
    statistical Method
    Conditional Logistic Regression
  8. ci Lower Limit
    0.77
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.37
    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, hysterectomy, current estrogen, prior estrogen, benign breast disease.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.8520
    param Type
    Odds Ratio (OR)
    param Value
    1.03
    statistical Method
    Conditional Logistic Regression
  9. ci Lower Limit
    1.01
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.06
    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
    0.0459
    param Type
    Odds Ratio (OR)
    param Value
    1.44
    statistical Method
    Conditional Logistic Regression
  10. ci Lower Limit
    0.99
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.04
    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, hysterectomy, current estrogen, prior estrogen, benign breast disease.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0542
    param Type
    Odds Ratio (OR)
    param Value
    1.42
    statistical Method
    Conditional Logistic Regression
  11. ci Lower Limit
    1.03
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.74
    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
    0.0312
    param Type
    Odds Ratio (OR)
    param Value
    1.34
    statistical Method
    Conditional Logistic Regression
  12. ci Lower Limit
    1.00
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.70
    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, hysterectomy, current estrogen, prior estrogen, benign breast disease.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0508
    param Type
    Odds Ratio (OR)
    param Value
    1.30
    statistical Method
    Conditional Logistic Regression
Complete source fields
analyses
  1. ci Lower Limit
    0.77
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.68
    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
    0.5043
    param Type
    Odds Ratio (OR)
    param Value
    1.14
    statistical Method
    Conditional Logistic Regression
  2. ci Lower Limit
    0.73
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.59
    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, hysterectomy, current estrogen, prior estrogen, benign breast disease.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.7129
    param Type
    Odds Ratio (OR)
    param Value
    1.08
    statistical Method
    Conditional Logistic Regression
  3. ci Lower Limit
    0.91
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.57
    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
    0.2055
    param Type
    Odds Ratio (OR)
    param Value
    1.19
    statistical Method
    Conditional Logistic Regression
  4. ci Lower Limit
    0.88
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.52
    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, hysterectomy, current estrogen, prior estrogen, benign breast disease.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.3005
    param Type
    Odds Ratio (OR)
    param Value
    1.16
    statistical Method
    Conditional Logistic Regression
  5. ci Lower Limit
    0.84
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.77
    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
    0.2849
    param Type
    Odds Ratio (OR)
    param Value
    1.22
    statistical Method
    Conditional Logistic Regression
  6. ci Lower Limit
    0.82
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.72
    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, hysterectomy, current estrogen, prior estrogen, benign breast disease.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.3650
    param Type
    Odds Ratio (OR)
    param Value
    1.19
    statistical Method
    Conditional Logistic Regression
  7. ci Lower Limit
    0.78
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.40
    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
    0.7559
    param Type
    Odds Ratio (OR)
    param Value
    1.05
    statistical Method
    Conditional Logistic Regression
  8. ci Lower Limit
    0.77
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.37
    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, hysterectomy, current estrogen, prior estrogen, benign breast disease.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.8520
    param Type
    Odds Ratio (OR)
    param Value
    1.03
    statistical Method
    Conditional Logistic Regression
  9. ci Lower Limit
    1.01
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.06
    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
    0.0459
    param Type
    Odds Ratio (OR)
    param Value
    1.44
    statistical Method
    Conditional Logistic Regression
  10. ci Lower Limit
    0.99
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.04
    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, hysterectomy, current estrogen, prior estrogen, benign breast disease.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0542
    param Type
    Odds Ratio (OR)
    param Value
    1.42
    statistical Method
    Conditional Logistic Regression
  11. ci Lower Limit
    1.03
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.74
    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
    0.0312
    param Type
    Odds Ratio (OR)
    param Value
    1.34
    statistical Method
    Conditional Logistic Regression
  12. ci Lower Limit
    1.00
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.70
    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, hysterectomy, current estrogen, prior estrogen, benign breast disease.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0508
    param Type
    Odds Ratio (OR)
    param Value
    1.30
    statistical Method
    Conditional Logistic Regression
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        19468
      2. group Id
        OG001
        value
        188199
    title
    Never (with 2 year lag)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        29
      2. group Id
        OG001
        value
        245
    title
    Tertile 1 (with 2 year lag)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        32
      2. group Id
        OG001
        value
        247
    title
    Tertile 2 (with 2 year lag)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        35
      2. group Id
        OG001
        value
        233
    title
    Tertile 3 (with 2 year lag)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        19390
      2. group Id
        OG001
        value
        187532
    title
    Never (without 2 year lag)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        58
      2. group Id
        OG001
        value
        465
    title
    Tertile 1 (without 2 year lag)
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        52
      2. group Id
        OG001
        value
        473
    title
    Tertile 2 (without 2 year lag)
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        64
      2. group Id
        OG001
        value
        454
    title
    Tertile 3 (without 2 year lag)
denoms
  1. counts
    1. group Id
      OG000
      value
      19564
    2. group Id
      OG001
      value
      188924
    units
    Participants
description
Incident breast 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. Tertile's with 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.56 months), and Tertile 3 (5.57 - 105.82 months). Tertile's without 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.72 months), and Tertile 3 (5.73 - 123.70 months).
groups
  1. description
    Patients with incident breast cancer defined from READ/OXMIS codes in the years 1995-2008
    id
    OG000
    title
    Incident Breast Cancer Patients
  2. description
    Cancer-free control patients risk set matched with incident breast 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 Breast 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 breast 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 Breast Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin
type
PRIMARY
unit Of Measure
participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice