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NCT01236053 · OUTCOME

Number of Breast Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions

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 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), Tertile 3 (8-298 prescriptions). Tertiles without 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), and Tertile 3 (8-388 prescriptions).

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

Cases

Cases

Controls

Controls

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

Analysis denominator · Participants

GroupSource count
Cases19564
Controls188924

Reported measurements

Never (with 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cases19468Not reportedNot reportedNot reportedNot reported
Controls188199Not reportedNot reportedNot reportedNot reported
Tertile 1 (with 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cases38Not reportedNot reportedNot reportedNot reported
Controls306Not reportedNot reportedNot reportedNot reported
Tertile 2 (with 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cases24Not reportedNot reportedNot reportedNot reported
Controls182Not reportedNot reportedNot reportedNot reported
Tertile 3 (with 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cases34Not reportedNot reportedNot reportedNot reported
Controls237Not reportedNot reportedNot reportedNot reported
Never (without 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cases19390Not reportedNot reportedNot reportedNot reported
Controls187532Not reportedNot reportedNot reportedNot reported
Tertile 1 (without 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cases75Not reportedNot reportedNot reportedNot reported
Controls577Not reportedNot reportedNot reportedNot reported
Tertile 2 (without 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cases32Not reportedNot reportedNot reportedNot reported
Controls355Not reportedNot reportedNot reportedNot reported
Tertile 3 (without 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cases67Not reportedNot reportedNot reportedNot reported
Controls460Not 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
    0.86
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.69
    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
    0.2893
    param Type
    Odds Ratio (OR)
    param Value
    1.20
    statistical Method
    Conditional Logistic Regression
  2. ci Lower Limit
    0.82
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.61
    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
    0.4301
    param Type
    Odds Ratio (OR)
    param Value
    1.15
    statistical Method
    Conditional Logistic Regression
  3. ci Lower Limit
    0.97
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.58
    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
    0.0806
    param Type
    Odds Ratio (OR)
    param Value
    1.24
    statistical Method
    Conditional Logistic Regression
  4. ci Lower Limit
    0.95
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.55
    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
    0.1226
    param Type
    Odds Ratio (OR)
    param Value
    1.21
    statistical Method
    Conditional Logistic Regression
  5. ci Lower Limit
    0.80
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.89
    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
    0.3502
    param Type
    Odds Ratio (OR)
    param Value
    1.23
    statistical Method
    Conditional Logistic Regression
  6. ci Lower Limit
    0.76
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.81
    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
    0.4654
    param Type
    Odds Ratio (OR)
    param Value
    1.17
    statistical Method
    Conditional Logistic Regression
  7. ci Lower Limit
    0.59
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.23
    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
    0.3987
    param Type
    Odds Ratio (OR)
    param Value
    0.86
    statistical Method
    Conditional Logistic Regression
  8. ci Lower Limit
    0.58
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.20
    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
    0.3349
    param Type
    Odds Ratio (OR)
    param Value
    0.84
    statistical Method
    Conditional Logistic Regression
  9. ci Lower Limit
    0.96
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.98
    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
    0.0827
    param Type
    Odds Ratio (OR)
    param Value
    1.38
    statistical Method
    Conditional Logistic Regression
  10. ci Lower Limit
    0.95
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.96
    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
    0.0932
    param Type
    Odds Ratio (OR)
    param Value
    1.36
    statistical Method
    Conditional Logistic Regression
  11. ci Lower Limit
    1.07
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.80
    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
    0.0130
    param Type
    Odds Ratio (OR)
    param Value
    1.39
    statistical Method
    Conditional Logistic Regression
  12. ci Lower Limit
    1.04
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.75
    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
    0.0241
    param Type
    Odds Ratio (OR)
    param Value
    1.35
    statistical Method
    Conditional Logistic Regression
Complete source fields
analyses
  1. ci Lower Limit
    0.86
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.69
    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
    0.2893
    param Type
    Odds Ratio (OR)
    param Value
    1.20
    statistical Method
    Conditional Logistic Regression
  2. ci Lower Limit
    0.82
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.61
    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
    0.4301
    param Type
    Odds Ratio (OR)
    param Value
    1.15
    statistical Method
    Conditional Logistic Regression
  3. ci Lower Limit
    0.97
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.58
    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
    0.0806
    param Type
    Odds Ratio (OR)
    param Value
    1.24
    statistical Method
    Conditional Logistic Regression
  4. ci Lower Limit
    0.95
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.55
    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
    0.1226
    param Type
    Odds Ratio (OR)
    param Value
    1.21
    statistical Method
    Conditional Logistic Regression
  5. ci Lower Limit
    0.80
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.89
    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
    0.3502
    param Type
    Odds Ratio (OR)
    param Value
    1.23
    statistical Method
    Conditional Logistic Regression
  6. ci Lower Limit
    0.76
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.81
    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
    0.4654
    param Type
    Odds Ratio (OR)
    param Value
    1.17
    statistical Method
    Conditional Logistic Regression
  7. ci Lower Limit
    0.59
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.23
    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
    0.3987
    param Type
    Odds Ratio (OR)
    param Value
    0.86
    statistical Method
    Conditional Logistic Regression
  8. ci Lower Limit
    0.58
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.20
    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
    0.3349
    param Type
    Odds Ratio (OR)
    param Value
    0.84
    statistical Method
    Conditional Logistic Regression
  9. ci Lower Limit
    0.96
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.98
    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
    0.0827
    param Type
    Odds Ratio (OR)
    param Value
    1.38
    statistical Method
    Conditional Logistic Regression
  10. ci Lower Limit
    0.95
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.96
    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
    0.0932
    param Type
    Odds Ratio (OR)
    param Value
    1.36
    statistical Method
    Conditional Logistic Regression
  11. ci Lower Limit
    1.07
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.80
    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
    0.0130
    param Type
    Odds Ratio (OR)
    param Value
    1.39
    statistical Method
    Conditional Logistic Regression
  12. ci Lower Limit
    1.04
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.75
    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
    0.0241
    param Type
    Odds Ratio (OR)
    param Value
    1.35
    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
        38
      2. group Id
        OG001
        value
        306
    title
    Tertile 1 (with 2 year lag)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        24
      2. group Id
        OG001
        value
        182
    title
    Tertile 2 (with 2 year lag)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        34
      2. group Id
        OG001
        value
        237
    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
        75
      2. group Id
        OG001
        value
        577
    title
    Tertile 1 (without 2 year lag)
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        32
      2. group Id
        OG001
        value
        355
    title
    Tertile 2 (without 2 year lag)
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        67
      2. group Id
        OG001
        value
        460
    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 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), Tertile 3 (8-298 prescriptions). Tertiles without 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), and Tertile 3 (8-388 prescriptions).
groups
  1. description
    Cases
    id
    OG000
    title
    Cases
  2. description
    Controls
    id
    OG001
    title
    Controls
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 Number of Gabapentin Prescriptions
type
PRIMARY
unit Of Measure
participants

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