Trial Outcomes & Findings for International Active Surveillance Study of Women Taking Oral Contraceptives (INAS-OC) (NCT NCT00335257)
NCT ID: NCT00335257
Last Updated: 2019-08-07
Results Overview
Venous thromboembolism (VTE) hazard ratio for oral contraceptives containing both drospirenone (DRSP) and ethinylestradiol (EE) in a 24-day regimen or any oral contraceptive without DRSP.
Recruitment status
COMPLETED
Target enrollment
85109 participants
Primary outcome timeframe
Within 60 months
Results posted on
2019-08-07
Participant Flow
Overall, 91,474 patients were recruited for the INAS-OC study. Of these, 6,365 participants were excluded due to protocol violations.
Participant milestones
| Measure |
OC DRSP-24d
OCs containing DRSP (Yaz®, 24 day regimen)
|
OC DRSP-21d
OCs containing DRSP (Yasmin®, 21 day regimen)
|
OCs Non-DRSP
Users of OCs containing other progestins
|
|---|---|---|---|
|
Overall Study
STARTED
|
15542
|
9377
|
60190
|
|
Overall Study
COMPLETED
|
15542
|
9377
|
60190
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
International Active Surveillance Study of Women Taking Oral Contraceptives (INAS-OC)
Baseline characteristics by cohort
| Measure |
OC DRSP-24d
n=15542 Participants
OCs containing DRSP (Yaz®, 24 day regimen )
|
OC DRSP-21d
n=9377 Participants
OCs containing DRSP (Yasmin®, 21 day regimen)
|
OCs Non-DRSP
n=60190 Participants
Users of OCs containing other progestins
|
Total
n=85109 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
2054 Participants
n=5 Participants
|
1149 Participants
n=7 Participants
|
7582 Participants
n=5 Participants
|
10785 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13488 Participants
n=5 Participants
|
8227 Participants
n=7 Participants
|
52608 Participants
n=5 Participants
|
74323 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Continuous
|
26.21 years
STANDARD_DEVIATION 7.64 • n=5 Participants
|
26.14 years
STANDARD_DEVIATION 7.48 • n=7 Participants
|
26.34 years
STANDARD_DEVIATION 7.73 • n=5 Participants
|
26.29 years
STANDARD_DEVIATION 7.69 • n=4 Participants
|
|
Sex: Female, Male
Female
|
15542 Participants
n=5 Participants
|
9377 Participants
n=7 Participants
|
60190 Participants
n=5 Participants
|
85109 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
922 participants
n=5 Participants
|
1438 participants
n=7 Participants
|
11207 participants
n=5 Participants
|
13567 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
10299 participants
n=5 Participants
|
3978 participants
n=7 Participants
|
37892 participants
n=5 Participants
|
52169 participants
n=4 Participants
|
|
Region of Enrollment
Austria
|
738 participants
n=5 Participants
|
611 participants
n=7 Participants
|
2945 participants
n=5 Participants
|
4294 participants
n=4 Participants
|
|
Region of Enrollment
Croatia
|
509 participants
n=5 Participants
|
68 participants
n=7 Participants
|
371 participants
n=5 Participants
|
948 participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
1644 participants
n=5 Participants
|
1427 participants
n=7 Participants
|
2657 participants
n=5 Participants
|
5728 participants
n=4 Participants
|
|
Region of Enrollment
Poland
|
1169 participants
n=5 Participants
|
1457 participants
n=7 Participants
|
3664 participants
n=5 Participants
|
6290 participants
n=4 Participants
|
|
Region of Enrollment
Sweden
|
261 participants
n=5 Participants
|
398 participants
n=7 Participants
|
1454 participants
n=5 Participants
|
2113 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Within 60 monthsPopulation: Study participants that were not excluded due to protocol violation
Venous thromboembolism (VTE) hazard ratio for oral contraceptives containing both drospirenone (DRSP) and ethinylestradiol (EE) in a 24-day regimen or any oral contraceptive without DRSP.
Outcome measures
| Measure |
OC DRSP-24d
n=7264 Participants
24-day regimen of DRSP/EE
|
OC DRSP-21d
n=5605 Participants
21-day regimen of DRSP/EE
|
OCs Non-DRSP
n=39316 Participants
Users of OCs containing other progestins than DRSP
|
NOHC
n=4070 Participants
Non-oral hormonal contraception (injections, implants, levonorgestrel-containing IUDs, or contraceptive patches)
|
No Use
n=28854 Participants
No (hormonal) contraception at last contact
|
|---|---|---|---|---|---|
|
Venous Thromboembolism (VTE); Hazard Ratio for DRSP-24 Day vs. Non-DRSP OCs
|
19 participants
|
16 participants
|
101 participants
|
7 participants
|
19 participants
|
PRIMARY outcome
Timeframe: Within 60 monthsPopulation: Study participants that were not excluded due to protocol violation
Arterial thromboembolism (ATE) in women using oral contraceptives containing both drospirenone (DRSP) and ethinylestradiol (EE) in a 24-day regimen or any oral contraceptive without DRSP. Cox regression analysis was not carried out. In accordance to the analysis plan, hazard ratios were only to be calculated if a minimum of 5 confirmed events were available in each of the comparison groups.
Outcome measures
| Measure |
OC DRSP-24d
n=7264 Participants
24-day regimen of DRSP/EE
|
OC DRSP-21d
n=5605 Participants
21-day regimen of DRSP/EE
|
OCs Non-DRSP
n=39316 Participants
Users of OCs containing other progestins than DRSP
|
NOHC
n=4070 Participants
Non-oral hormonal contraception (injections, implants, levonorgestrel-containing IUDs, or contraceptive patches)
|
No Use
n=28854 Participants
No (hormonal) contraception at last contact
|
|---|---|---|---|---|---|
|
Arterial Thromboembolism (ATE), Hazard Ratio for DRSP-24 Day vs. Non-DRSP OCs
Total number of ATE
|
4 participants
|
3 participants
|
30 participants
|
2 participants
|
7 participants
|
|
Arterial Thromboembolism (ATE), Hazard Ratio for DRSP-24 Day vs. Non-DRSP OCs
of which acute myocardial infarction
|
2 participants
|
0 participants
|
10 participants
|
1 participants
|
3 participants
|
|
Arterial Thromboembolism (ATE), Hazard Ratio for DRSP-24 Day vs. Non-DRSP OCs
of which ichemic stroke
|
1 participants
|
3 participants
|
15 participants
|
0 participants
|
2 participants
|
|
Arterial Thromboembolism (ATE), Hazard Ratio for DRSP-24 Day vs. Non-DRSP OCs
of which transient ischemic attack (TIA)
|
1 participants
|
0 participants
|
3 participants
|
0 participants
|
2 participants
|
|
Arterial Thromboembolism (ATE), Hazard Ratio for DRSP-24 Day vs. Non-DRSP OCs
of which peripheral ATE
|
0 participants
|
0 participants
|
2 participants
|
1 participants
|
0 participants
|
Adverse Events
DRSP-24d
Serious events: 583 serious events
Other events: 0 other events
Deaths: 0 deaths
DRSP-21d
Serious events: 499 serious events
Other events: 0 other events
Deaths: 0 deaths
OCs Non-DRSP
Serious events: 2740 serious events
Other events: 0 other events
Deaths: 0 deaths
NOHC
Serious events: 254 serious events
Other events: 0 other events
Deaths: 0 deaths
No Use
Serious events: 1756 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DRSP-24d
n=7264 participants at risk
24-day regimen of DRSP/EE
|
DRSP-21d
n=5605 participants at risk
21-day regimen of DRSP/EE
|
OCs Non-DRSP
n=39316 participants at risk
Users of OCs containing other progestins
|
NOHC
n=4070 participants at risk
Non-oral hormonal contraception (injections, implants, levonorgestrel-containing IUDs, or patches)
|
No Use
n=28854 participants at risk
No (hormonal) contraception)
|
|---|---|---|---|---|---|
|
Infections and infestations
Infectious diseases
|
0.51%
37/7264 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.57%
32/5605 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.35%
137/39316 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.34%
14/4070 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.24%
68/28854 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms, malignant
|
0.36%
26/7264 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.25%
14/5605 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.30%
119/39316 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.17%
7/4070 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.20%
57/28854 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms, benign
|
0.08%
6/7264 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.09%
5/5605 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.09%
36/39316 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.02%
1/4070 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.05%
14/28854 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
|
Blood and lymphatic system disorders
Diseases of the blood and blood-forming organs
|
0.06%
4/7264 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.09%
5/5605 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.03%
12/39316 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.07%
3/4070 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.05%
15/28854 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
|
Endocrine disorders
Endocrine diseases
|
0.17%
12/7264 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.14%
8/5605 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.12%
47/39316 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.12%
5/4070 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.09%
26/28854 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
|
Psychiatric disorders
Psychiatric and neurological disorders
|
0.73%
53/7264 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.57%
32/5605 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.57%
226/39316 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.57%
23/4070 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.38%
109/28854 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
|
Eye disorders
Eye
|
0.01%
1/7264 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.04%
2/5605 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.04%
14/39316 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.00%
0/4070 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.02%
7/28854 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
|
Ear and labyrinth disorders
Ear
|
0.04%
3/7264 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.12%
7/5605 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.02%
9/39316 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.02%
1/4070 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.02%
6/28854 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
|
Cardiac disorders
Cardiovascular system
|
0.56%
41/7264 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.91%
51/5605 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.71%
278/39316 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.71%
29/4070 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.34%
98/28854 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory system
|
0.54%
39/7264 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.54%
30/5605 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.47%
183/39316 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.44%
18/4070 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.27%
77/28854 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
|
Gastrointestinal disorders
Digestive system
|
2.0%
145/7264 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
2.1%
116/5605 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
1.4%
553/39316 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
1.4%
56/4070 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.90%
259/28854 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
|
Skin and subcutaneous tissue disorders
Skin
|
0.06%
4/7264 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.18%
10/5605 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.10%
40/39316 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.05%
2/4070 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.04%
12/28854 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal system and connective tissue
|
0.17%
12/7264 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.27%
15/5605 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.21%
81/39316 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.22%
9/4070 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.17%
48/28854 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
|
Reproductive system and breast disorders
Genitourinary system
|
1.3%
93/7264 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
1.3%
74/5605 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
1.2%
471/39316 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
1.1%
44/4070 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.88%
253/28854 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy, delivery and puerperium
|
0.30%
22/7264 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.57%
32/5605 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.38%
151/39316 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.22%
9/4070 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
2.0%
571/28854 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
|
Injury, poisoning and procedural complications
Injury, poisoning, accidents, etc
|
1.2%
85/7264 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
1.2%
66/5605 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.97%
383/39316 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.81%
33/4070 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
0.47%
136/28854 • Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
|
Other adverse events
Adverse event data not reported
Additional Information
Juergen Dinger, MD, PhD
Center for Epidemiology and Health Research, Germany
Phone: 0049(0)30 945 10120
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place