NCT01236053 · OUTCOME
Number of Breast 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 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 (0.1 - 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 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
| Group | Source count |
|---|
| Incident Breast Cancer Patients | 19564 |
|---|
| Matched Controls for Incident Breast Cancer Patients | 188924 |
|---|
Reported measurements
Never (with 2 year lag)
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Incident Breast Cancer Patients | 19468 | Not reported | Not reported | Not reported | Not reported |
|---|
| Matched Controls for Incident Breast Cancer Patients | 188199 | Not reported | Not reported | Not reported | Not reported |
|---|
Tertile 1 (with 2 year lag)
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Incident Breast Cancer Patients | 31 | Not reported | Not reported | Not reported | Not reported |
|---|
| Matched Controls for Incident Breast Cancer Patients | 254 | Not reported | Not reported | Not reported | Not reported |
|---|
Tertile 2 (with 2 year lag)
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Incident Breast Cancer Patients | 30 | Not reported | Not reported | Not reported | Not reported |
|---|
| Matched Controls for Incident Breast Cancer Patients | 225 | Not reported | Not reported | Not reported | Not reported |
|---|
Tertile 3 (with 2 year lag)
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Incident Breast Cancer Patients | 35 | Not reported | Not reported | Not reported | Not reported |
|---|
| Matched Controls for Incident Breast Cancer Patients | 246 | Not reported | Not reported | Not reported | Not reported |
|---|
Never (without 2 year lag)
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Incident Breast Cancer Patients | 19390 | Not reported | Not reported | Not reported | Not reported |
|---|
| Matched Controls for Incident Breast Cancer Patients | 187532 | Not reported | Not reported | Not reported | Not reported |
|---|
Tertile 1 (without 2 year lag)
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Incident Breast Cancer Patients | 66 | Not reported | Not reported | Not reported | Not reported |
|---|
| Matched Controls for Incident Breast Cancer Patients | 493 | Not reported | Not reported | Not reported | Not reported |
|---|
Tertile 2 (without 2 year lag)
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Incident Breast Cancer Patients | 44 | Not reported | Not reported | Not reported | Not reported |
|---|
| Matched Controls for Incident Breast Cancer Patients | 423 | Not reported | Not reported | Not reported | Not reported |
|---|
Tertile 3 (without 2 year lag)
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Incident Breast Cancer Patients | 64 | Not reported | Not reported | Not reported | Not reported |
|---|
| Matched Controls for Incident Breast Cancer Patients | 476 | Not reported | Not reported | Not reported | Not reported |
|---|
Source statistical analyses
Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.
- ci Lower Limit
- 0.80
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.70
- estimate Comment
- Comparison: "Tertile 1 (with 2 year lag)" and "Never (with 2 year lag)".
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.4233
- param Type
- Odds Ratio (OR)
- param Value
- 1.17
- statistical Method
- Conditional Logistic Regression
- ci Lower Limit
- 0.76
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.62
- 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.
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.5908
- param Type
- Odds Ratio (OR)
- param Value
- 1.11
- statistical Method
- Conditional Logistic Regression
- ci Lower Limit
- 1.00
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.67
- estimate Comment
- Comparison: "Tertile 1 (without 2 year lag)" and "Never (without 2 year lag)".
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0540
- param Type
- Odds Ratio (OR)
- param Value
- 1.29
- statistical Method
- Conditional Logistic Regression
- ci Lower Limit
- 0.96
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.62
- 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.
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0939
- param Type
- Odds Ratio (OR)
- param Value
- 1.25
- statistical Method
- Conditional Logistic Regression
- ci Lower Limit
- 0.87
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.87
- estimate Comment
- Comparison: "Tertile 2 (with 2 year lag)" and "Never (with 2 year lag)".
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.2140
- param Type
- Odds Ratio (OR)
- param Value
- 1.27
- statistical Method
- Conditional Logistic Regression
- ci Lower Limit
- 0.84
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.80
- 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.
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.2940
- param Type
- Odds Ratio (OR)
- param Value
- 1.23
- statistical Method
- Conditional Logistic Regression
- ci Lower Limit
- 0.71
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.32
- estimate Comment
- Comparison: "Tertile 2 (without 2 year lag)" and "Never (without 2 year lag)".
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.8352
- param Type
- Odds Ratio (OR)
- param Value
- 0.97
- statistical Method
- Conditional Logistic Regression
- ci Lower Limit
- 0.70
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.31
- 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.
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.7809
- param Type
- Odds Ratio (OR)
- param Value
- 0.96
- statistical Method
- Conditional Logistic Regression
- ci Lower Limit
- 0.95
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.94
- estimate Comment
- Comparison: "Tertile 3 (with 2 year lag)" and "Never (with 2 year lag)".
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0921
- param Type
- Odds Ratio (OR)
- param Value
- 1.36
- statistical Method
- Conditional Logistic Regression
- ci Lower Limit
- 0.94
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.92
- 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.
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.1091
- param Type
- Odds Ratio (OR)
- param Value
- 1.34
- statistical Method
- Conditional Logistic Regression
- ci Lower Limit
- 0.99
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.68
- estimate Comment
- Comparison: "Tertile 3 (without 2 year lag)" and "Never (without 2 year lag)".
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0564
- param Type
- Odds Ratio (OR)
- param Value
- 1.29
- statistical Method
- Conditional Logistic Regression
- ci Lower Limit
- 0.96
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.63
- 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.
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0939
- param Type
- Odds Ratio (OR)
- param Value
- 1.25
- statistical Method
- Conditional Logistic Regression
Complete source fields
- analyses
- ci Lower Limit
- 0.80
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.70
- estimate Comment
- Comparison: "Tertile 1 (with 2 year lag)" and "Never (with 2 year lag)".
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.4233
- param Type
- Odds Ratio (OR)
- param Value
- 1.17
- statistical Method
- Conditional Logistic Regression
- ci Lower Limit
- 0.76
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.62
- 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.
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.5908
- param Type
- Odds Ratio (OR)
- param Value
- 1.11
- statistical Method
- Conditional Logistic Regression
- ci Lower Limit
- 1.00
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.67
- estimate Comment
- Comparison: "Tertile 1 (without 2 year lag)" and "Never (without 2 year lag)".
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0540
- param Type
- Odds Ratio (OR)
- param Value
- 1.29
- statistical Method
- Conditional Logistic Regression
- ci Lower Limit
- 0.96
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.62
- 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.
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0939
- param Type
- Odds Ratio (OR)
- param Value
- 1.25
- statistical Method
- Conditional Logistic Regression
- ci Lower Limit
- 0.87
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.87
- estimate Comment
- Comparison: "Tertile 2 (with 2 year lag)" and "Never (with 2 year lag)".
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.2140
- param Type
- Odds Ratio (OR)
- param Value
- 1.27
- statistical Method
- Conditional Logistic Regression
- ci Lower Limit
- 0.84
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.80
- 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.
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.2940
- param Type
- Odds Ratio (OR)
- param Value
- 1.23
- statistical Method
- Conditional Logistic Regression
- ci Lower Limit
- 0.71
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.32
- estimate Comment
- Comparison: "Tertile 2 (without 2 year lag)" and "Never (without 2 year lag)".
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.8352
- param Type
- Odds Ratio (OR)
- param Value
- 0.97
- statistical Method
- Conditional Logistic Regression
- ci Lower Limit
- 0.70
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.31
- 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.
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.7809
- param Type
- Odds Ratio (OR)
- param Value
- 0.96
- statistical Method
- Conditional Logistic Regression
- ci Lower Limit
- 0.95
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.94
- estimate Comment
- Comparison: "Tertile 3 (with 2 year lag)" and "Never (with 2 year lag)".
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0921
- param Type
- Odds Ratio (OR)
- param Value
- 1.36
- statistical Method
- Conditional Logistic Regression
- ci Lower Limit
- 0.94
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.92
- 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.
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.1091
- param Type
- Odds Ratio (OR)
- param Value
- 1.34
- statistical Method
- Conditional Logistic Regression
- ci Lower Limit
- 0.99
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.68
- estimate Comment
- Comparison: "Tertile 3 (without 2 year lag)" and "Never (without 2 year lag)".
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0564
- param Type
- Odds Ratio (OR)
- param Value
- 1.29
- statistical Method
- Conditional Logistic Regression
- ci Lower Limit
- 0.96
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.63
- 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.
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0939
- param Type
- Odds Ratio (OR)
- param Value
- 1.25
- statistical Method
- Conditional Logistic Regression
- classes
- categories
- measurements
- group Id
- OG000
- value
- 19468
- group Id
- OG001
- value
- 188199
- title
- Never (with 2 year lag)
- categories
- measurements
- group Id
- OG000
- value
- 31
- group Id
- OG001
- value
- 254
- title
- Tertile 1 (with 2 year lag)
- categories
- measurements
- group Id
- OG000
- value
- 30
- group Id
- OG001
- value
- 225
- title
- Tertile 2 (with 2 year lag)
- categories
- measurements
- group Id
- OG000
- value
- 35
- group Id
- OG001
- value
- 246
- title
- Tertile 3 (with 2 year lag)
- categories
- measurements
- group Id
- OG000
- value
- 19390
- group Id
- OG001
- value
- 187532
- title
- Never (without 2 year lag)
- categories
- measurements
- group Id
- OG000
- value
- 66
- group Id
- OG001
- value
- 493
- title
- Tertile 1 (without 2 year lag)
- categories
- measurements
- group Id
- OG000
- value
- 44
- group Id
- OG001
- value
- 423
- title
- Tertile 2 (without 2 year lag)
- categories
- measurements
- group Id
- OG000
- value
- 64
- group Id
- OG001
- value
- 476
- title
- Tertile 3 (without 2 year lag)
- denoms
- counts
- group Id
- OG000
- value
- 19564
- 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 (0.1 - 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
- description
- Patients with incident breast cancer defined from READ/OXMIS codes in the years 1995-2008
- id
- OG000
- title
- Incident Breast Cancer Patients
- 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 Cumulative Dose of Gabapentin
- type
- PRIMARY
- unit Of Measure
- participants
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