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NCT01236053 · OUTCOME

Number of Pancreatic 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 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 pancreatic 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 (0.1 - 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 Pancreatic Cancer Patients

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

Matched Controls for Incident Pancreatic Cancer Patients

Cancer-free control patients risk set matched with incident pancreatic 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 Pancreatic Cancer Patients2155
Matched Controls for Incident Pancreatic Cancer Patients20382

Reported measurements

Never (with 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Incident Pancreatic Cancer Patients2135Not reportedNot reportedNot reportedNot reported
Matched Controls for Incident Pancreatic Cancer Patients20296Not reportedNot reportedNot reportedNot reported
Tertile 1 (with 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Incident Pancreatic Cancer Patients9Not reportedNot reportedNot reportedNot reported
Matched Controls for Incident Pancreatic Cancer Patients33Not reportedNot reportedNot reportedNot reported
Tertile 2 (with 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Incident Pancreatic Cancer Patients6Not reportedNot reportedNot reportedNot reported
Matched Controls for Incident Pancreatic Cancer Patients22Not reportedNot reportedNot reportedNot reported
Tertile 3 (with 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Incident Pancreatic Cancer Patients5Not reportedNot reportedNot reportedNot reported
Matched Controls for Incident Pancreatic Cancer Patients31Not reportedNot reportedNot reportedNot reported
Never (without 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Incident Pancreatic Cancer Patients2120Not reportedNot reportedNot reportedNot reported
Matched Controls for Incident Pancreatic Cancer Patients20222Not reportedNot reportedNot reportedNot reported
Tertile 1 (without 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Incident Pancreatic Cancer Patients15Not reportedNot reportedNot reportedNot reported
Matched Controls for Incident Pancreatic Cancer Patients56Not reportedNot reportedNot reportedNot reported
Tertile 2 (without 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Incident Pancreatic Cancer Patients8Not reportedNot reportedNot reportedNot reported
Matched Controls for Incident Pancreatic Cancer Patients45Not reportedNot reportedNot reportedNot reported
Tertile 3 (without 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Incident Pancreatic Cancer Patients12Not reportedNot reportedNot reportedNot reported
Matched Controls for Incident Pancreatic Cancer Patients59Not 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
    1.12
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.09
    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
    0.0248
    param Type
    Odds Ratio (OR)
    param Value
    2.38
    statistical Method
    Conditional Logistic Regression
  2. ci Lower Limit
    0.99
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    4.70
    estimate Comment
    Comparison: "Tertile 1 (with 2 year lag)" and "Never (with 2 year lag)". Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0520
    param Type
    Odds Ratio (OR)
    param Value
    2.16
    statistical Method
    Conditional Logistic Regression
  3. ci Lower Limit
    1.30
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    4.20
    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
    0.0046
    param Type
    Odds Ratio (OR)
    param Value
    2.33
    statistical Method
    Conditional Logistic Regression
  4. ci Lower Limit
    1.12
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    3.72
    estimate Comment
    Comparison: "Tertile 1 (without 2 year lag)" and "Never (without 2 year lag)". Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0193
    param Type
    Odds Ratio (OR)
    param Value
    2.05
    statistical Method
    Wilcoxon (Mann-Whitney)
  5. ci Lower Limit
    1.10
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    6.88
    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
    0.0309
    param Type
    Odds Ratio (OR)
    param Value
    2.75
    statistical Method
    Conditional Logistic Regression
  6. ci Lower Limit
    0.81
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.51
    estimate Comment
    Comparison: "Tertile 2 (with 2 year lag)" and "Never (with 2 year lag)". Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.1285
    param Type
    Odds Ratio (OR)
    param Value
    2.11
    statistical Method
    Conditional Logistic Regression
  7. ci Lower Limit
    0.85
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    3.83
    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
    0.1257
    param Type
    Odds Ratio (OR)
    param Value
    1.80
    statistical Method
    Conditional Logistic Regression
  8. ci Lower Limit
    0.70
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    3.31
    estimate Comment
    Comparison: "Tertile 2 (without 2 year lag)" and "Never (without 2 year lag)". Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.2944
    param Type
    Odds Ratio (OR)
    param Value
    1.52
    statistical Method
    Conditional Logistic Regression
  9. ci Lower Limit
    0.45
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    3.21
    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
    0.7032
    param Type
    Odds Ratio (OR)
    param Value
    1.21
    statistical Method
    Conditional Logistic Regression
  10. ci Lower Limit
    0.37
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.69
    estimate Comment
    Comparison: "Tertile 3 (with 2 year lag)" and "Never (with 2 year lag)". Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.9922
    param Type
    Odds Ratio (OR)
    param Value
    1.00
    statistical Method
    Conditional Logistic Regression
  11. ci Lower Limit
    0.87
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    3.16
    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
    0.1227
    param Type
    Odds Ratio (OR)
    param Value
    1.66
    statistical Method
    Conditional Logistic Regression
  12. ci Lower Limit
    0.69
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.61
    estimate Comment
    Comparison: "Tertile 3 (without 2 year lag)" and "Never (without 2 year lag)". Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.3809
    param Type
    Odds Ratio (OR)
    param Value
    1.34
    statistical Method
    Conditional Logistic Regression
Complete source fields
analyses
  1. ci Lower Limit
    1.12
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.09
    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
    0.0248
    param Type
    Odds Ratio (OR)
    param Value
    2.38
    statistical Method
    Conditional Logistic Regression
  2. ci Lower Limit
    0.99
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    4.70
    estimate Comment
    Comparison: "Tertile 1 (with 2 year lag)" and "Never (with 2 year lag)". Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0520
    param Type
    Odds Ratio (OR)
    param Value
    2.16
    statistical Method
    Conditional Logistic Regression
  3. ci Lower Limit
    1.30
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    4.20
    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
    0.0046
    param Type
    Odds Ratio (OR)
    param Value
    2.33
    statistical Method
    Conditional Logistic Regression
  4. ci Lower Limit
    1.12
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    3.72
    estimate Comment
    Comparison: "Tertile 1 (without 2 year lag)" and "Never (without 2 year lag)". Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0193
    param Type
    Odds Ratio (OR)
    param Value
    2.05
    statistical Method
    Wilcoxon (Mann-Whitney)
  5. ci Lower Limit
    1.10
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    6.88
    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
    0.0309
    param Type
    Odds Ratio (OR)
    param Value
    2.75
    statistical Method
    Conditional Logistic Regression
  6. ci Lower Limit
    0.81
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.51
    estimate Comment
    Comparison: "Tertile 2 (with 2 year lag)" and "Never (with 2 year lag)". Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.1285
    param Type
    Odds Ratio (OR)
    param Value
    2.11
    statistical Method
    Conditional Logistic Regression
  7. ci Lower Limit
    0.85
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    3.83
    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
    0.1257
    param Type
    Odds Ratio (OR)
    param Value
    1.80
    statistical Method
    Conditional Logistic Regression
  8. ci Lower Limit
    0.70
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    3.31
    estimate Comment
    Comparison: "Tertile 2 (without 2 year lag)" and "Never (without 2 year lag)". Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.2944
    param Type
    Odds Ratio (OR)
    param Value
    1.52
    statistical Method
    Conditional Logistic Regression
  9. ci Lower Limit
    0.45
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    3.21
    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
    0.7032
    param Type
    Odds Ratio (OR)
    param Value
    1.21
    statistical Method
    Conditional Logistic Regression
  10. ci Lower Limit
    0.37
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.69
    estimate Comment
    Comparison: "Tertile 3 (with 2 year lag)" and "Never (with 2 year lag)". Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.9922
    param Type
    Odds Ratio (OR)
    param Value
    1.00
    statistical Method
    Conditional Logistic Regression
  11. ci Lower Limit
    0.87
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    3.16
    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
    0.1227
    param Type
    Odds Ratio (OR)
    param Value
    1.66
    statistical Method
    Conditional Logistic Regression
  12. ci Lower Limit
    0.69
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.61
    estimate Comment
    Comparison: "Tertile 3 (without 2 year lag)" and "Never (without 2 year lag)". Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.3809
    param Type
    Odds Ratio (OR)
    param Value
    1.34
    statistical Method
    Conditional Logistic Regression
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2135
      2. group Id
        OG001
        value
        20296
    title
    Never (with 2 year lag)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        33
    title
    Tertile 1 (with 2 year lag)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        22
    title
    Tertile 2 (with 2 year lag)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        31
    title
    Tertile 3 (with 2 year lag)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2120
      2. group Id
        OG001
        value
        20222
    title
    Never (without 2 year lag)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        56
    title
    Tertile 1 (without 2 year lag)
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        45
    title
    Tertile 2 (without 2 year lag)
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        59
    title
    Tertile 3 (without 2 year lag)
denoms
  1. counts
    1. group Id
      OG000
      value
      2155
    2. group Id
      OG001
      value
      20382
    units
    Participants
description
Incident pancreatic 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 (0.1 - 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 incident pancreatic cancer defined from READ/OXMIS codes in the years 1995-2008
    id
    OG000
    title
    Incident Pancreatic Cancer Patients
  2. description
    Cancer-free control patients risk set matched with incident pancreatic 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 Pancreatic 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 Pancreatic Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin
type
PRIMARY
unit Of Measure
participants

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Preserved source evidence · Not medical advice