NCT01236053 · OUTCOME
Number of Bladder 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 bladder 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 bladder 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 Bladder Cancer Patients
Patients with incident bladder cancer defined from READ/OXMIS codes in the years 1995-2008
Matched Controls for Incident Bladder Cancer Patients
Cancer-free control patients risk set matched with incident bladder 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 Bladder Cancer Patients | 4600 |
|---|
| Matched Controls for Incident Bladder Cancer Patients | 43559 |
|---|
Reported measurements
Never (with 2 year lag)
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Incident Bladder Cancer Patients | 4585 | Not reported | Not reported | Not reported | Not reported |
|---|
| Matched Controls for Incident Bladder Cancer Patients | 43415 | 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 Bladder Cancer Patients | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Matched Controls for Incident Bladder Cancer Patients | 52 | 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 Bladder Cancer Patients | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Matched Controls for Incident Bladder Cancer Patients | 51 | 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 Bladder Cancer Patients | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Matched Controls for Incident Bladder Cancer Patients | 41 | 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 Bladder Cancer Patients | 4567 | Not reported | Not reported | Not reported | Not reported |
|---|
| Matched Controls for Incident Bladder Cancer Patients | 43260 | 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 Bladder Cancer Patients | 14 | Not reported | Not reported | Not reported | Not reported |
|---|
| Matched Controls for Incident Bladder Cancer Patients | 112 | 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 Bladder Cancer Patients | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
| Matched Controls for Incident Bladder Cancer Patients | 103 | 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 Bladder Cancer Patients | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Matched Controls for Incident Bladder Cancer Patients | 84 | 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
- 0.48
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.59
- estimate Comment
- Comparison: "Tertile 1 (with 2 year lag)" and "Never (with 2 year lag)".
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.8111
- param Type
- Odds Ratio (OR)
- param Value
- 1.11
- statistical Method
- Conditional Logistic Regression
- ci Lower Limit
- 0.45
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.46
- 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.
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.9104
- param Type
- Odds Ratio (OR)
- param Value
- 1.05
- statistical Method
- Conditional Logistic Regression
- ci Lower Limit
- 0.68
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.07
- estimate Comment
- Comparison: "Tertile 1 (without 2 year lag)" and "Never (without 2 year lag)".
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.5592
- param Type
- Odds Ratio (OR)
- param Value
- 1.18
- statistical Method
- Conditional Logistic Regression
- ci Lower Limit
- 0.60
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.85
- 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.
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.8521
- param Type
- Odds Ratio (OR)
- param Value
- 1.06
- statistical Method
- Conditional Logistic Regression
- ci Lower Limit
- 0.26
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.04
- estimate Comment
- Comparison: "Tertile 2 (with 2 year lag)" and "Never (with 2 year lag)".
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.5529
- param Type
- Odds Ratio (OR)
- param Value
- 0.73
- statistical Method
- Conditional Logistic Regression
- ci Lower Limit
- 0.21
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.68
- 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.
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.3275
- param Type
- Adjusted Odds Ratio
- param Value
- 0.60
- statistical Method
- Conditional Logistic Regression
- ci Lower Limit
- 0.46
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.72
- estimate Comment
- Comparison: "Tertile 2 (without 2 year lag)" and "Never (without 2 year lag)".
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.7300
- param Type
- Odds Ratio (OR)
- param Value
- 0.89
- statistical Method
- Conditional Logistic Regression
- ci Lower Limit
- 0.41
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.53
- 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.
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.4831
- param Type
- Odds Ratio (OR)
- param Value
- 0.79
- statistical Method
- Conditional Logistic Regression
- ci Lower Limit
- 0.45
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.92
- estimate Comment
- Comparison: "Tertile 3 (with 2 year lag)" and "Never (with 2 year lag)".
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.7693
- param Type
- Odds Ratio (OR)
- param Value
- 1.15
- statistical Method
- Conditional Logistic Regression
- ci Lower Limit
- 0.35
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.30
- 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.
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.8189
- param Type
- Odds Ratio (OR)
- param Value
- 0.90
- statistical Method
- Conditional Logistic Regression
- ci Lower Limit
- 0.50
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.98
- estimate Comment
- Comparison: "Tertile 3 (without 2 year lag)" and "Never (without 2 year lag)".
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.9800
- param Type
- Odds Ratio (OR)
- param Value
- 0.99
- statistical Method
- Conditional Logistic Regression
- ci Lower Limit
- 0.39
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.58
- 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.
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.4944
- param Type
- Odds Ratio (OR)
- param Value
- 0.78
- statistical Method
- Conditional Logistic Regression
Complete source fields
- analyses
- ci Lower Limit
- 0.48
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.59
- estimate Comment
- Comparison: "Tertile 1 (with 2 year lag)" and "Never (with 2 year lag)".
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.8111
- param Type
- Odds Ratio (OR)
- param Value
- 1.11
- statistical Method
- Conditional Logistic Regression
- ci Lower Limit
- 0.45
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.46
- 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.
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.9104
- param Type
- Odds Ratio (OR)
- param Value
- 1.05
- statistical Method
- Conditional Logistic Regression
- ci Lower Limit
- 0.68
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.07
- estimate Comment
- Comparison: "Tertile 1 (without 2 year lag)" and "Never (without 2 year lag)".
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.5592
- param Type
- Odds Ratio (OR)
- param Value
- 1.18
- statistical Method
- Conditional Logistic Regression
- ci Lower Limit
- 0.60
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.85
- 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.
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.8521
- param Type
- Odds Ratio (OR)
- param Value
- 1.06
- statistical Method
- Conditional Logistic Regression
- ci Lower Limit
- 0.26
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.04
- estimate Comment
- Comparison: "Tertile 2 (with 2 year lag)" and "Never (with 2 year lag)".
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.5529
- param Type
- Odds Ratio (OR)
- param Value
- 0.73
- statistical Method
- Conditional Logistic Regression
- ci Lower Limit
- 0.21
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.68
- 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.
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.3275
- param Type
- Adjusted Odds Ratio
- param Value
- 0.60
- statistical Method
- Conditional Logistic Regression
- ci Lower Limit
- 0.46
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.72
- estimate Comment
- Comparison: "Tertile 2 (without 2 year lag)" and "Never (without 2 year lag)".
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.7300
- param Type
- Odds Ratio (OR)
- param Value
- 0.89
- statistical Method
- Conditional Logistic Regression
- ci Lower Limit
- 0.41
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.53
- 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.
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.4831
- param Type
- Odds Ratio (OR)
- param Value
- 0.79
- statistical Method
- Conditional Logistic Regression
- ci Lower Limit
- 0.45
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.92
- estimate Comment
- Comparison: "Tertile 3 (with 2 year lag)" and "Never (with 2 year lag)".
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.7693
- param Type
- Odds Ratio (OR)
- param Value
- 1.15
- statistical Method
- Conditional Logistic Regression
- ci Lower Limit
- 0.35
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.30
- 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.
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.8189
- param Type
- Odds Ratio (OR)
- param Value
- 0.90
- statistical Method
- Conditional Logistic Regression
- ci Lower Limit
- 0.50
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.98
- estimate Comment
- Comparison: "Tertile 3 (without 2 year lag)" and "Never (without 2 year lag)".
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.9800
- param Type
- Odds Ratio (OR)
- param Value
- 0.99
- statistical Method
- Conditional Logistic Regression
- ci Lower Limit
- 0.39
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.58
- 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.
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.4944
- param Type
- Odds Ratio (OR)
- param Value
- 0.78
- statistical Method
- Conditional Logistic Regression
- classes
- categories
- measurements
- group Id
- OG000
- value
- 4585
- group Id
- OG001
- value
- 43415
- title
- Never (with 2 year lag)
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 52
- title
- Tertile 1 (with 2 year lag)
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 51
- title
- Tertile 2 (with 2 year lag)
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 41
- title
- Tertile 3 (with 2 year lag)
- categories
- measurements
- group Id
- OG000
- value
- 4567
- group Id
- OG001
- value
- 43260
- title
- Never (without 2 year lag)
- categories
- measurements
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 112
- title
- Tertile 1 (without 2 year lag)
- categories
- measurements
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 103
- title
- Tertile 2 (without 2 year lag)
- categories
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 84
- title
- Tertile 3 (without 2 year lag)
- denoms
- counts
- group Id
- OG000
- value
- 4600
- group Id
- OG001
- value
- 43559
- units
- Participants
- description
- Incident bladder 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 bladder cancer defined from READ/OXMIS codes in the years 1995-2008
- id
- OG000
- title
- Incident Bladder Cancer Patients
- description
- Cancer-free control patients risk set matched with incident bladder 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 Bladder 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 bladder 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 Bladder Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin
- type
- PRIMARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle