Trial Outcomes & Findings for Carcinogenicity Study of Bupropion (NCT NCT01077596)
NCT ID: NCT01077596
Last Updated: 2017-05-30
Results Overview
The following are the cancers under investigation: colorectal, lung, bladder, uterus, breast, and prostate. Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.
Recruitment status
COMPLETED
Target enrollment
50430 participants
Primary outcome timeframe
January 1, 1996 - December 31, 2006
Results posted on
2017-05-30
Participant Flow
Patients were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymized and used to develop a patient cohort. All diagnoses and treatment are recorded in the course of routine medical practice.
Participant milestones
| Measure |
New Antidepressant Exposure in Colorectal Cancer: Cases
New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Colorectal Cancer: Cases
|
New Antidepressant Exposure in Colorectal Cancer: Controls
New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Colorectal Cancer: Controls
|
New Antidepressant Exposure in Lung Cancer: Cases
New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Lung Cancer: Cases
|
New Antidepressant Exposure in Lung Cancer: Controls
New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Lung Cancer: Controls
|
New Antidepressant Exposure in Bladder Cancer: Cases
New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Bladder Cancer: Cases
|
New Antidepressant Exposure in Bladder Cancer: Controls
New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Bladder Cancer: Controls
|
Antidepressant Exposure in Uterine Cancer: Cases
New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Uterine Cancer: Cases
|
New Antidepressant Exposure in Uterine Cancer: Controls
New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Uterine Cancer: Controls
|
New Antidepressant Exposure in Breast Cancer: Cases
New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Breast Cancer: Cases
|
New Antidepressant Exposure in Breast Cancer: Controls
New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Breast Cancer: Controls
|
New Antidepressant Exposure in Prostate Cancer: Cases
New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Prostate Cancer: Cases
|
New Antidepressant Exposure in Prostate Cancer: Controls
New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Prostate Cancer: Controls
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
350
|
1050
|
457
|
1370
|
294
|
882
|
308
|
837
|
2842
|
28420
|
2215
|
22150
|
|
Overall Study
COMPLETED
|
350
|
1050
|
457
|
1370
|
294
|
882
|
308
|
837
|
2842
|
28420
|
2215
|
22150
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Carcinogenicity Study of Bupropion
Baseline characteristics by cohort
| Measure |
New Antidepressant Exposure in Colorectal Cancer: Cases
n=350 Participants
New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Colorectal Cancer: Cases
|
New Antidepressant Exposure in Colorectal Cancer: Controls
n=1050 Participants
New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Colorectal Cancer: Controls
|
New Antidepressant Exposure in Lung Cancer: Cases
n=457 Participants
New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Lung Cancer: Cases
|
New Antidepressant Exposure in Lung Cancer: Controls
n=1370 Participants
New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Lung Cancer: Controls
|
New Antidepressant Exposure in Bladder Cancer: Cases
n=294 Participants
New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Bladder Cancer: Cases
|
New Antidepressant Exposure in Bladder Cancer: Controls
n=882 Participants
New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Bladder Cancer: Controls
|
New Antidepressant Exposure in Uterine Cancer: Cases
n=308 Participants
New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Uterine Cancer: Cases
|
New Antidepressant Exposure in Uterine Cancer: Controls
n=837 Participants
New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Uterine Cancer: Controls
|
New Antidepressant Exposure in Breast Cancer: Cases
n=2842 Participants
New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Breast Cancer: Cases
|
New Antidepressant Exposure in Breast Cancer: Controls
n=28420 Participants
New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Breast Cancer: Controls
|
New Antidepressant Exposure in Prostate Cancer: Cases
n=2215 Participants
New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Prostate Cancer: Cases
|
New Antidepressant Exposure in Prostate Cancer: Controls
n=22150 Participants
New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Prostate Cancer: Controls
|
Total
n=61175 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
45-54 years
|
34 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
140 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
51 Participants
n=10 Participants
|
59 Participants
n=115 Participants
|
172 Participants
n=6 Participants
|
678 Participants
n=6 Participants
|
6780 Participants
n=64 Participants
|
193 Participants
n=17 Participants
|
1930 Participants
n=21 Participants
|
10203 Participants
n=22 Participants
|
|
Age, Customized
55-64 years
|
73 Participants
n=5 Participants
|
219 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
306 Participants
n=4 Participants
|
63 Participants
n=21 Participants
|
189 Participants
n=10 Participants
|
90 Participants
n=115 Participants
|
245 Participants
n=6 Participants
|
849 Participants
n=6 Participants
|
8490 Participants
n=64 Participants
|
669 Participants
n=17 Participants
|
6690 Participants
n=21 Participants
|
17985 Participants
n=22 Participants
|
|
Age, Customized
65-74 years
|
119 Participants
n=5 Participants
|
357 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
477 Participants
n=4 Participants
|
104 Participants
n=21 Participants
|
312 Participants
n=10 Participants
|
84 Participants
n=115 Participants
|
224 Participants
n=6 Participants
|
707 Participants
n=6 Participants
|
7070 Participants
n=64 Participants
|
877 Participants
n=17 Participants
|
8770 Participants
n=21 Participants
|
19260 Participants
n=22 Participants
|
|
Age, Customized
>=75 years
|
124 Participants
n=5 Participants
|
372 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
447 Participants
n=4 Participants
|
110 Participants
n=21 Participants
|
330 Participants
n=10 Participants
|
75 Participants
n=115 Participants
|
196 Participants
n=6 Participants
|
608 Participants
n=6 Participants
|
6080 Participants
n=64 Participants
|
476 Participants
n=17 Participants
|
4760 Participants
n=21 Participants
|
13727 Participants
n=22 Participants
|
|
Sex: Female, Male
Female
|
126 Participants
n=5 Participants
|
378 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
525 Participants
n=4 Participants
|
91 Participants
n=21 Participants
|
273 Participants
n=10 Participants
|
308 Participants
n=115 Participants
|
837 Participants
n=6 Participants
|
2842 Participants
n=6 Participants
|
28420 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
33975 Participants
n=22 Participants
|
|
Sex: Female, Male
Male
|
224 Participants
n=5 Participants
|
672 Participants
n=7 Participants
|
282 Participants
n=5 Participants
|
845 Participants
n=4 Participants
|
203 Participants
n=21 Participants
|
609 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
2215 Participants
n=17 Participants
|
22150 Participants
n=21 Participants
|
27200 Participants
n=22 Participants
|
|
Number of participants diagnosed with the indicated conditions and using the indicated therapies
Exposed to multiple antidepressants
|
47 participants
n=5 Participants
|
160 participants
n=7 Participants
|
62 participants
n=5 Participants
|
191 participants
n=4 Participants
|
44 participants
n=21 Participants
|
147 participants
n=10 Participants
|
53 participants
n=115 Participants
|
162 participants
n=6 Participants
|
564 participants
n=6 Participants
|
5756 participants
n=64 Participants
|
340 participants
n=17 Participants
|
3782 participants
n=21 Participants
|
11308 participants
n=22 Participants
|
|
Number of participants diagnosed with the indicated conditions and using the indicated therapies
Ever smokers
|
252 participants
n=5 Participants
|
643 participants
n=7 Participants
|
428 participants
n=5 Participants
|
772 participants
n=4 Participants
|
247 participants
n=21 Participants
|
573 participants
n=10 Participants
|
142 participants
n=115 Participants
|
389 participants
n=6 Participants
|
0 participants
n=6 Participants
|
0 participants
n=64 Participants
|
0 participants
n=17 Participants
|
0 participants
n=21 Participants
|
3446 participants
n=22 Participants
|
|
Number of participants diagnosed with the indicated conditions and using the indicated therapies
Unknown smoking status
|
4 participants
n=5 Participants
|
70 participants
n=7 Participants
|
5 participants
n=5 Participants
|
183 participants
n=4 Participants
|
1 participants
n=21 Participants
|
29 participants
n=10 Participants
|
4 participants
n=115 Participants
|
27 participants
n=6 Participants
|
0 participants
n=6 Participants
|
0 participants
n=64 Participants
|
0 participants
n=17 Participants
|
0 participants
n=21 Participants
|
323 participants
n=22 Participants
|
|
Number of participants diagnosed with the indicated conditions and using the indicated therapies
Ever diagnosed (dx) with depression
|
110 participants
n=5 Participants
|
329 participants
n=7 Participants
|
108 participants
n=5 Participants
|
408 participants
n=4 Participants
|
83 participants
n=21 Participants
|
273 participants
n=10 Participants
|
119 participants
n=115 Participants
|
319 participants
n=6 Participants
|
1091 participants
n=6 Participants
|
10541 participants
n=64 Participants
|
677 participants
n=17 Participants
|
6700 participants
n=21 Participants
|
20758 participants
n=22 Participants
|
|
Number of participants diagnosed with the indicated conditions and using the indicated therapies
Ever dx with inflammatory bowel disease (IBD)
|
1 participants
n=5 Participants
|
9 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
0 participants
n=6 Participants
|
0 participants
n=6 Participants
|
0 participants
n=64 Participants
|
0 participants
n=17 Participants
|
0 participants
n=21 Participants
|
10 participants
n=22 Participants
|
|
Number of participants diagnosed with the indicated conditions and using the indicated therapies
Users of oral contraceptives (OC)
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
8 participants
n=115 Participants
|
45 participants
n=6 Participants
|
236 participants
n=6 Participants
|
1987 participants
n=64 Participants
|
0 participants
n=17 Participants
|
0 participants
n=21 Participants
|
2289 participants
n=22 Participants
|
|
Number of participants diagnosed with the indicated conditions and using the indicated therapies
Users of hormone replacement therapy (HRT)
|
57 participants
n=5 Participants
|
225 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
153 participants
n=115 Participants
|
441 participants
n=6 Participants
|
1796 participants
n=6 Participants
|
17184 participants
n=64 Participants
|
0 participants
n=17 Participants
|
0 participants
n=21 Participants
|
19856 participants
n=22 Participants
|
|
Number of participants diagnosed with the indicated conditions and using the indicated therapies
Users of NSAIDs
|
269 participants
n=5 Participants
|
859 participants
n=7 Participants
|
370 participants
n=5 Participants
|
1123 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
0 participants
n=6 Participants
|
2340 participants
n=6 Participants
|
23730 participants
n=64 Participants
|
1800 participants
n=17 Participants
|
17887 participants
n=21 Participants
|
48378 participants
n=22 Participants
|
PRIMARY outcome
Timeframe: January 1, 1996 - December 31, 2006Population: Participants diagnosed with colorectal, lung, bladder, uterus, breast, or prostate cancer who were new antidepressant users
The following are the cancers under investigation: colorectal, lung, bladder, uterus, breast, and prostate. Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.
Outcome measures
| Measure |
Bupropion, Regular Use
n=8038 Participants
Regular Bupropion use was defined as 4 times per week for 3 months at least 12 months before index date
|
All Non-bupropion Antidepressants, Regular Use
n=42392 Participants
Regular antidepressant use of non-bupropion was defined as use of non-bupropion antidepressant for 4 times per week for 3 months at least 12 months before index date
|
Tricyclic Antidepressants (TCA), Regular Use
n=18537 Participants
Regular TCA use was defined as use of TCA for 4 times per week for 3 months at least 12 months before index date
|
Selective Serotonin Reuptake Inhibitors (SSRI), Regular Use
n=23740 Participants
Regular SSRI use was defined as use of SSRI antidepressant for 4 times per week for 3 months at least 12 months before index date
|
Other Antidepressants, Regular Use
n=10123 Participants
Regular "other" antidepressant use was defined as use other antidepressant aside from Bupropion, TCA, and SSRI for 4 times per week for 3 months at least 12 months before index date
|
|---|---|---|---|---|---|
|
Number of Participants Diagnosed With Any of the Cancers Under Investigation Who Were Regularly Exposed to the Indicated Antidepressant
Cases
|
853 participants
|
4561 participants
|
1963 participants
|
2570 participants
|
1027 participants
|
|
Number of Participants Diagnosed With Any of the Cancers Under Investigation Who Were Regularly Exposed to the Indicated Antidepressant
Controls
|
6332 participants
|
37831 participants
|
16574 participants
|
21170 participants
|
9096 participants
|
SECONDARY outcome
Timeframe: January 1, 1996 - December 31, 2006Population: Participants diagnosed with colorectal cancer who were new antidepressant users.
In this outcome, colorectal cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Colorectal cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.
Outcome measures
| Measure |
Bupropion, Regular Use
n=126 Participants
Regular Bupropion use was defined as 4 times per week for 3 months at least 12 months before index date
|
All Non-bupropion Antidepressants, Regular Use
n=973 Participants
Regular antidepressant use of non-bupropion was defined as use of non-bupropion antidepressant for 4 times per week for 3 months at least 12 months before index date
|
Tricyclic Antidepressants (TCA), Regular Use
n=432 Participants
Regular TCA use was defined as use of TCA for 4 times per week for 3 months at least 12 months before index date
|
Selective Serotonin Reuptake Inhibitors (SSRI), Regular Use
n=545 Participants
Regular SSRI use was defined as use of SSRI antidepressant for 4 times per week for 3 months at least 12 months before index date
|
Other Antidepressants, Regular Use
n=201 Participants
Regular "other" antidepressant use was defined as use other antidepressant aside from Bupropion, TCA, and SSRI for 4 times per week for 3 months at least 12 months before index date
|
|---|---|---|---|---|---|
|
Number of Participants Diagnosed With Colorectal Cancer Who Were Regularly Exposed to the Indicated Antidepressant
Cases
|
37 participants
|
234 participants
|
111 participants
|
134 participants
|
35 participants
|
|
Number of Participants Diagnosed With Colorectal Cancer Who Were Regularly Exposed to the Indicated Antidepressant
Controls
|
89 participants
|
739 participants
|
321 participants
|
411 participants
|
166 participants
|
SECONDARY outcome
Timeframe: January 1, 1996 - December 31, 2006Population: Participants diagnosed with lung cancer who were new antidepressant users.
In this outcome, lung cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Lung cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.
Outcome measures
| Measure |
Bupropion, Regular Use
n=240 Participants
Regular Bupropion use was defined as 4 times per week for 3 months at least 12 months before index date
|
All Non-bupropion Antidepressants, Regular Use
n=1172 Participants
Regular antidepressant use of non-bupropion was defined as use of non-bupropion antidepressant for 4 times per week for 3 months at least 12 months before index date
|
Tricyclic Antidepressants (TCA), Regular Use
n=498 Participants
Regular TCA use was defined as use of TCA for 4 times per week for 3 months at least 12 months before index date
|
Selective Serotonin Reuptake Inhibitors (SSRI), Regular Use
n=670 Participants
Regular SSRI use was defined as use of SSRI antidepressant for 4 times per week for 3 months at least 12 months before index date
|
Other Antidepressants, Regular Use
n=233 Participants
Regular "other" antidepressant use was defined as use other antidepressant aside from Bupropion, TCA, and SSRI for 4 times per week for 3 months at least 12 months before index date
|
|---|---|---|---|---|---|
|
Number of Participants Diagnosed With Lung Cancer Who Were Regularly Exposed to the Indicated Antidepressant
Cases
|
115 participants
|
250 participants
|
109 participants
|
138 participants
|
47 participants
|
|
Number of Participants Diagnosed With Lung Cancer Who Were Regularly Exposed to the Indicated Antidepressant
Controls
|
125 participants
|
922 participants
|
389 participants
|
532 participants
|
186 participants
|
SECONDARY outcome
Timeframe: January 1, 1996 - December 31, 2006Population: Participants diagnosed with bladder cancer who were new antidepressant users.
In this outcome, bladder cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Bladder cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.
Outcome measures
| Measure |
Bupropion, Regular Use
n=125 Participants
Regular Bupropion use was defined as 4 times per week for 3 months at least 12 months before index date
|
All Non-bupropion Antidepressants, Regular Use
n=853 Participants
Regular antidepressant use of non-bupropion was defined as use of non-bupropion antidepressant for 4 times per week for 3 months at least 12 months before index date
|
Tricyclic Antidepressants (TCA), Regular Use
n=385 Participants
Regular TCA use was defined as use of TCA for 4 times per week for 3 months at least 12 months before index date
|
Selective Serotonin Reuptake Inhibitors (SSRI), Regular Use
n=454 Participants
Regular SSRI use was defined as use of SSRI antidepressant for 4 times per week for 3 months at least 12 months before index date
|
Other Antidepressants, Regular Use
n=199 Participants
Regular "other" antidepressant use was defined as use other antidepressant aside from Bupropion, TCA, and SSRI for 4 times per week for 3 months at least 12 months before index date
|
|---|---|---|---|---|---|
|
Number of Participants Diagnosed With Bladder Cancer Who Were Regularly Exposed to the Indicated Antidepressant
Controls
|
77 participants
|
662 participants
|
297 participants
|
351 participants
|
159 participants
|
|
Number of Participants Diagnosed With Bladder Cancer Who Were Regularly Exposed to the Indicated Antidepressant
Cases
|
48 participants
|
191 participants
|
88 participants
|
103 participants
|
40 participants
|
SECONDARY outcome
Timeframe: January 1, 1996 - December 31, 2006Population: Participants diagnosed with uterine cancer who were new antidepressant users.
In this outcome, uterine cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Uterine cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.
Outcome measures
| Measure |
Bupropion, Regular Use
n=116 Participants
Regular Bupropion use was defined as 4 times per week for 3 months at least 12 months before index date
|
All Non-bupropion Antidepressants, Regular Use
n=866 Participants
Regular antidepressant use of non-bupropion was defined as use of non-bupropion antidepressant for 4 times per week for 3 months at least 12 months before index date
|
Tricyclic Antidepressants (TCA), Regular Use
n=371 Participants
Regular TCA use was defined as use of TCA for 4 times per week for 3 months at least 12 months before index date
|
Selective Serotonin Reuptake Inhibitors (SSRI), Regular Use
n=484 Participants
Regular SSRI use was defined as use of SSRI antidepressant for 4 times per week for 3 months at least 12 months before index date
|
Other Antidepressants, Regular Use
n=210 Participants
Regular "other" antidepressant use was defined as use other antidepressant aside from Bupropion, TCA, and SSRI for 4 times per week for 3 months at least 12 months before index date
|
|---|---|---|---|---|---|
|
Number of Participants Diagnosed With Uterine Cancer Who Were Regularly Exposed to the Indicated Antidepressant
Cases
|
25 participants
|
233 participants
|
114 participants
|
124 participants
|
45 participants
|
|
Number of Participants Diagnosed With Uterine Cancer Who Were Regularly Exposed to the Indicated Antidepressant
Controls
|
91 participants
|
633 participants
|
257 participants
|
360 participants
|
165 participants
|
SECONDARY outcome
Timeframe: January 1, 1996 - December 31, 2006Population: Participants diagnosed with breast cancer who were new antidepressant users.
In this outcome, breast cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Breast cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.
Outcome measures
| Measure |
Bupropion, Regular Use
n=3268 Participants
Regular Bupropion use was defined as 4 times per week for 3 months at least 12 months before index date
|
All Non-bupropion Antidepressants, Regular Use
n=23361 Participants
Regular antidepressant use of non-bupropion was defined as use of non-bupropion antidepressant for 4 times per week for 3 months at least 12 months before index date
|
Tricyclic Antidepressants (TCA), Regular Use
n=10279 Participants
Regular TCA use was defined as use of TCA for 4 times per week for 3 months at least 12 months before index date
|
Selective Serotonin Reuptake Inhibitors (SSRI), Regular Use
n=13454 Participants
Regular SSRI use was defined as use of SSRI antidepressant for 4 times per week for 3 months at least 12 months before index date
|
Other Antidepressants, Regular Use
n=5638 Participants
Regular "other" antidepressant use was defined as use other antidepressant aside from Bupropion, TCA, and SSRI for 4 times per week for 3 months at least 12 months before index date
|
|---|---|---|---|---|---|
|
Number of Participants Diagnosed With Breast Cancer Who Were Regularly Exposed to the Indicated Antidepressant
Cases
|
302 participants
|
2173 participants
|
941 participants
|
1265 participants
|
497 participants
|
|
Number of Participants Diagnosed With Breast Cancer Who Were Regularly Exposed to the Indicated Antidepressant
Controls
|
2966 participants
|
21188 participants
|
9338 participants
|
12189 participants
|
5141 participants
|
SECONDARY outcome
Timeframe: January 1, 1996 - December 31, 2006Population: Participants diagnosed with prostate cancer who were new antidepressant users.
In this outcome, prostate cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Prostate cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.
Outcome measures
| Measure |
Bupropion, Regular Use
n=3550 Participants
Regular Bupropion use was defined as 4 times per week for 3 months at least 12 months before index date
|
All Non-bupropion Antidepressants, Regular Use
n=17042 Participants
Regular antidepressant use of non-bupropion was defined as use of non-bupropion antidepressant for 4 times per week for 3 months at least 12 months before index date
|
Tricyclic Antidepressants (TCA), Regular Use
n=7436 Participants
Regular TCA use was defined as use of TCA for 4 times per week for 3 months at least 12 months before index date
|
Selective Serotonin Reuptake Inhibitors (SSRI), Regular Use
n=9112 Participants
Regular SSRI use was defined as use of SSRI antidepressant for 4 times per week for 3 months at least 12 months before index date
|
Other Antidepressants, Regular Use
n=4089 Participants
Regular "other" antidepressant use was defined as use other antidepressant aside from Bupropion, TCA, and SSRI for 4 times per week for 3 months at least 12 months before index date
|
|---|---|---|---|---|---|
|
Number of Participants Diagnosed With Prostate Cancer Who Were Regularly Exposed to the Indicated Antidepressant
Cases
|
326 participants
|
1480 participants
|
600 participants
|
806 participants
|
363 participants
|
|
Number of Participants Diagnosed With Prostate Cancer Who Were Regularly Exposed to the Indicated Antidepressant
Controls
|
3224 participants
|
15562 participants
|
6836 participants
|
8306 participants
|
3726 participants
|
Adverse Events
New Antidepressant Exposure in Colorectal Cancer: Cases
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
New Antidepressant Exposure in Colorectal Cancer: Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
New Antidepressant Exposure in Lung Cancer: Cases
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
New Antidepressant Exposure in Lung Cancer: Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
New Antidepressant Exposure in Bladder Cancer: Cases
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
New Antidepressant Exposure in Bladder Cancer: Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
New Antidepressant Exposure in Uterine Cancer: Cases
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
New Antidepressant Exposure in Uterine Cancer: Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
New Antidepressant Exposure in Breast Cancer: Cases
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
New Antidepressant Exposure in Breast Cancer: Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
New Antidepressant Exposure in Prostate Cancer: Cases
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
New Antidepressant Exposure in Prostate Cancer: Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER