Trial Outcomes & Findings for Transatlantic Active Surveillance on Cardiovascular Safety of NuvaRing (TASC) (NCT NCT00524771)

Last Updated: 2014-04-09

Results Overview

Venous thromboembolism (VTE) associated with the use of hormonal contraceptives that contain both an estrogen and progestin.

Recruitment status

COMPLETED

Target enrollment

34100 participants

Primary outcome timeframe

Time to event analysis within 48 months

Results posted on

2014-04-09

Participant Flow

Participant milestones

Participant milestones
Measure	NuvaRing Users of an etonogestrel-containing and ethinylestradiol-containing vaginal ring	Combined Oral Contraceptives (COC) Users of combined oral contraceptive pills
Overall Study STARTED	17084	17016
Overall Study COMPLETED	16864	16431
Overall Study NOT COMPLETED	220	585

Reasons for withdrawal

Reasons for withdrawal
Measure	NuvaRing Users of an etonogestrel-containing and ethinylestradiol-containing vaginal ring	Combined Oral Contraceptives (COC) Users of combined oral contraceptive pills
Overall Study Protocol Violation	220	585

Baseline Characteristics

Transatlantic Active Surveillance on Cardiovascular Safety of NuvaRing (TASC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NuvaRing n=16864 Participants Users of an etonogestrel-containing and ethinylestradiol-containing vaginal ring	Combined Oral Contraceptives (COC) n=16431 Participants Users of combined oral contraceptive pills	Total n=33295 Participants Total of all reporting groups
Age, Continuous	28.0 years STANDARD_DEVIATION 7.3 • n=5 Participants	26.9 years STANDARD_DEVIATION 7.6 • n=7 Participants	27.4 years STANDARD_DEVIATION 7.5 • n=5 Participants
Age, Categorical <=18 years	127 Participants n=5 Participants	406 Participants n=7 Participants	533 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16737 Participants n=5 Participants	16025 Participants n=7 Participants	32762 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	16864 Participants n=5 Participants	16431 Participants n=7 Participants	33295 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Europe	8215 participants n=5 Participants	7699 participants n=7 Participants	15914 participants n=5 Participants
Region of Enrollment United States	8649 participants n=5 Participants	8732 participants n=7 Participants	17381 participants n=5 Participants

PRIMARY outcome

Timeframe: Time to event analysis within 48 months

Population: Study participants that were not excluded due to protocol violations.

Venous thromboembolism (VTE) associated with the use of hormonal contraceptives that contain both an estrogen and progestin.

Outcome measures

Outcome measures
Measure	NuvaRing n=16864 Participants Users of an etonogestrel-containing and ethinylestradiol-containing vaginal ring	Combined Oral Contraceptives (COC) n=16431 Participants Users of combined oral contraceptive pills	COC2 n=13811 Participants A priori defined subgroup of users of combined oral contraceptive pills without desogestrel or gestodene
Number of Participants With Venous Thromboembolism (VTE)	19 participants	26 participants	21 participants

PRIMARY outcome

Timeframe: Time to event analysis within 48 months

Arterial Thromboembolism (ATE) associated with the use of hormonal contraceptives that contain both an estrogen and progestin.

Outcome measures

Outcome measures
Measure	NuvaRing n=16864 Participants Users of an etonogestrel-containing and ethinylestradiol-containing vaginal ring	Combined Oral Contraceptives (COC) n=16431 Participants Users of combined oral contraceptive pills	COC2 n=13811 Participants A priori defined subgroup of users of combined oral contraceptive pills without desogestrel or gestodene
Number of Participants With Arterial Thromboembolism (ATE)	5 participants	8 participants	6 participants

Adverse Events

NuvaRing

Serious events: 577 serious events

Other events: 0 other events

Deaths: 0 deaths

Combined Oral Contraceptives (COC)

Serious events: 751 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Dr. Juergen Dinger

Center for Epidemiology and Health Research, Germany

Phone: 0049 (0)30 945 101 20

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	NuvaRing n=16864 participants at risk；n=17084 participants at risk Users of an etonogestrel-containing and ethinylestradiol-containing vaginal ring	Combined Oral Contraceptives (COC) n=16431 participants at risk；n=17016 participants at risk Users of combined oral contraceptive pills
Infections and infestations Infectious diseases	0.12% 20/17084 • Information on adverse events was collected over a period of 4 years. All study participants were asked for adverse events at each follow-up.	0.18% 30/17016 • Information on adverse events was collected over a period of 4 years. All study participants were asked for adverse events at each follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms, malignant	0.08% 14/17084 • Information on adverse events was collected over a period of 4 years. All study participants were asked for adverse events at each follow-up.	0.11% 19/17016 • Information on adverse events was collected over a period of 4 years. All study participants were asked for adverse events at each follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms, benign	0.05% 9/17084 • Information on adverse events was collected over a period of 4 years. All study participants were asked for adverse events at each follow-up.	0.06% 10/17016 • Information on adverse events was collected over a period of 4 years. All study participants were asked for adverse events at each follow-up.
Blood and lymphatic system disorders Diseases of the blood and blood-forming organs	0.02% 3/17084 • Information on adverse events was collected over a period of 4 years. All study participants were asked for adverse events at each follow-up.	0.02% 3/17016 • Information on adverse events was collected over a period of 4 years. All study participants were asked for adverse events at each follow-up.
Endocrine disorders Endocrine diseases	0.04% 7/17084 • Information on adverse events was collected over a period of 4 years. All study participants were asked for adverse events at each follow-up.	0.05% 8/17016 • Information on adverse events was collected over a period of 4 years. All study participants were asked for adverse events at each follow-up.
Psychiatric disorders Psychiatric & neurological disorders	0.25% 42/17084 • Information on adverse events was collected over a period of 4 years. All study participants were asked for adverse events at each follow-up.	0.31% 52/17016 • Information on adverse events was collected over a period of 4 years. All study participants were asked for adverse events at each follow-up.
Eye disorders Eye	0.02% 3/17084 • Information on adverse events was collected over a period of 4 years. All study participants were asked for adverse events at each follow-up.	0.03% 5/17016 • Information on adverse events was collected over a period of 4 years. All study participants were asked for adverse events at each follow-up.
Ear and labyrinth disorders Ear	0.05% 8/17084 • Information on adverse events was collected over a period of 4 years. All study participants were asked for adverse events at each follow-up.	0.05% 9/17016 • Information on adverse events was collected over a period of 4 years. All study participants were asked for adverse events at each follow-up.
Cardiac disorders Cardiovascular system	0.31% 53/17084 • Information on adverse events was collected over a period of 4 years. All study participants were asked for adverse events at each follow-up.	0.44% 75/17016 • Information on adverse events was collected over a period of 4 years. All study participants were asked for adverse events at each follow-up.
Respiratory, thoracic and mediastinal disorders Respiratory system	0.23% 40/17084 • Information on adverse events was collected over a period of 4 years. All study participants were asked for adverse events at each follow-up.	0.32% 54/17016 • Information on adverse events was collected over a period of 4 years. All study participants were asked for adverse events at each follow-up.
Gastrointestinal disorders Digestive system	0.74% 126/17084 • Information on adverse events was collected over a period of 4 years. All study participants were asked for adverse events at each follow-up.	0.99% 169/17016 • Information on adverse events was collected over a period of 4 years. All study participants were asked for adverse events at each follow-up.
Skin and subcutaneous tissue disorders Skin	0.11% 19/17084 • Information on adverse events was collected over a period of 4 years. All study participants were asked for adverse events at each follow-up.	0.13% 22/17016 • Information on adverse events was collected over a period of 4 years. All study participants were asked for adverse events at each follow-up.
Musculoskeletal and connective tissue disorders Muscosceletal system & connective tissue	0.11% 19/17084 • Information on adverse events was collected over a period of 4 years. All study participants were asked for adverse events at each follow-up.	0.15% 26/17016 • Information on adverse events was collected over a period of 4 years. All study participants were asked for adverse events at each follow-up.
Reproductive system and breast disorders Genitourinary system	0.66% 112/17084 • Information on adverse events was collected over a period of 4 years. All study participants were asked for adverse events at each follow-up.	0.85% 144/17016 • Information on adverse events was collected over a period of 4 years. All study participants were asked for adverse events at each follow-up.
Injury, poisoning and procedural complications Injury, poisening, accidents, etc	0.60% 102/17084 • Information on adverse events was collected over a period of 4 years. All study participants were asked for adverse events at each follow-up.	0.73% 125/17016 • Information on adverse events was collected over a period of 4 years. All study participants were asked for adverse events at each follow-up.