Trial Outcomes & Findings for The Incidence of Venous Thromboembolism in Atopic Dermatitis (NCT NCT04969653)
NCT ID: NCT04969653
Last Updated: 2024-12-09
Results Overview
To describe the risk of venous thromboembolism (composite of pulmonary embolism and deep vein thrombosis) in people with active AD compared to a matched control population.
Recruitment status
COMPLETED
Target enrollment
754745 participants
Primary outcome timeframe
10 years from index date
Results posted on
2024-12-09
Participant Flow
Participant milestones
| Measure |
Cases
All adults with an episode of active atopic dermatitis at any point between 1st Jan 2010 to 1st Jan 2015 will be included for analysis.
Exposure of venous thromboembolism: Composite of pulmonary embolism and deep vein thrombosis
|
Controls
Adults without atopic dermatitis or other skin conditions matched to cases by age, gender, and duration of practice registration.
Exposure of venous thromboembolism: Composite of pulmonary embolism and deep vein thrombosis
|
|---|---|---|
|
Overall Study
STARTED
|
150975
|
603770
|
|
Overall Study
COMPLETED
|
150975
|
603770
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Incidence of Venous Thromboembolism in Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Cases
n=150975 Participants
All adults with an episode of active atopic dermatitis at any point between 1st Jan 2010 to 1st Jan 2015 will be included for analysis.
Exposure of venous thromboembolism: Composite of pulmonary embolism and deep vein thrombosis
|
Controls
n=603770 Participants
Adults without atopic dermatitis or other skin conditions matched to cases by age, gender, and duration of practice registration.
Exposure of venous thromboembolism: Composite of pulmonary embolism and deep vein thrombosis
|
Total
n=754745 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.0 years
n=5 Participants
|
41.0 years
n=7 Participants
|
41.0 years
n=5 Participants
|
|
Age, Customized
18-29
|
54634 Participants
n=5 Participants
|
213727 Participants
n=7 Participants
|
268361 Participants
n=5 Participants
|
|
Age, Customized
30-39
|
20599 Participants
n=5 Participants
|
80118 Participants
n=7 Participants
|
100717 Participants
n=5 Participants
|
|
Age, Customized
40-49
|
17903 Participants
n=5 Participants
|
80211 Participants
n=7 Participants
|
98114 Participants
n=5 Participants
|
|
Age, Customized
50-59
|
15765 Participants
n=5 Participants
|
61343 Participants
n=7 Participants
|
77108 Participants
n=5 Participants
|
|
Age, Customized
60-69
|
17375 Participants
n=5 Participants
|
71571 Participants
n=7 Participants
|
88946 Participants
n=5 Participants
|
|
Age, Customized
70-79
|
15081 Participants
n=5 Participants
|
58452 Participants
n=7 Participants
|
73533 Participants
n=5 Participants
|
|
Age, Customized
80+
|
9618 Participants
n=5 Participants
|
38348 Participants
n=7 Participants
|
47966 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
89093 Participants
n=5 Participants
|
356311 Participants
n=7 Participants
|
445404 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
61882 Participants
n=5 Participants
|
247459 Participants
n=7 Participants
|
309341 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
87748 Participants
n=5 Participants
|
331717 Participants
n=7 Participants
|
419465 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian or Asian British
|
12635 Participants
n=5 Participants
|
38388 Participants
n=7 Participants
|
51023 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or Black British
|
2021 Participants
n=5 Participants
|
7903 Participants
n=7 Participants
|
9924 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed
|
1396 Participants
n=5 Participants
|
4281 Participants
n=7 Participants
|
5677 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not stated
|
4638 Participants
n=5 Participants
|
21349 Participants
n=7 Participants
|
25987 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
7503 Participants
n=5 Participants
|
26907 Participants
n=7 Participants
|
34410 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing
|
35034 Participants
n=5 Participants
|
173225 Participants
n=7 Participants
|
208259 Participants
n=5 Participants
|
|
GP visit in last 12 months
Yes
|
146440 Participants
n=5 Participants
|
536511 Participants
n=7 Participants
|
682951 Participants
n=5 Participants
|
|
GP visit in last 12 months
No
|
4535 Participants
n=5 Participants
|
67259 Participants
n=7 Participants
|
71794 Participants
n=5 Participants
|
|
BMI
< 18.5 Underweight
|
5931 Participants
n=5 Participants
|
24532 Participants
n=7 Participants
|
30463 Participants
n=5 Participants
|
|
BMI
18.5-24.9 Normal weight
|
46458 Participants
n=5 Participants
|
174953 Participants
n=7 Participants
|
221411 Participants
n=5 Participants
|
|
BMI
25-29.9 Overweight
|
43720 Participants
n=5 Participants
|
159607 Participants
n=7 Participants
|
203327 Participants
n=5 Participants
|
|
BMI
30-34.9 Class I obesity
|
21317 Participants
n=5 Participants
|
77432 Participants
n=7 Participants
|
98749 Participants
n=5 Participants
|
|
BMI
35-39.9 Class II obesity
|
8711 Participants
n=5 Participants
|
30258 Participants
n=7 Participants
|
38969 Participants
n=5 Participants
|
|
BMI
40+ Class III obesity
|
5353 Participants
n=5 Participants
|
17515 Participants
n=7 Participants
|
22868 Participants
n=5 Participants
|
|
BMI
Missing
|
19485 Participants
n=5 Participants
|
119473 Participants
n=7 Participants
|
138958 Participants
n=5 Participants
|
|
Smoking status
Never
|
45,152 Participants
n=5 Participants
|
189,107 Participants
n=7 Participants
|
234259 Participants
n=5 Participants
|
|
Smoking status
Current
|
27,173 Participants
n=5 Participants
|
116,895 Participants
n=7 Participants
|
144068 Participants
n=5 Participants
|
|
Smoking status
Ex-smoker
|
74,860 Participants
n=5 Participants
|
255,950 Participants
n=7 Participants
|
330810 Participants
n=5 Participants
|
|
Smoking status
Passive
|
770 Participants
n=5 Participants
|
1,904 Participants
n=7 Participants
|
2674 Participants
n=5 Participants
|
|
Smoking status
Missing
|
3020 Participants
n=5 Participants
|
39914 Participants
n=7 Participants
|
42934 Participants
n=5 Participants
|
|
Alcohol status
None
|
47083 Participants
n=5 Participants
|
170663 Participants
n=7 Participants
|
217746 Participants
n=5 Participants
|
|
Alcohol status
Within limits
|
58905 Participants
n=5 Participants
|
226953 Participants
n=7 Participants
|
285858 Participants
n=5 Participants
|
|
Alcohol status
Excess
|
18660 Participants
n=5 Participants
|
64716 Participants
n=7 Participants
|
83376 Participants
n=5 Participants
|
|
Alcohol status
Harmful
|
2374 Participants
n=5 Participants
|
8743 Participants
n=7 Participants
|
11117 Participants
n=5 Participants
|
|
Alcohol status
Missing
|
23953 Participants
n=5 Participants
|
132695 Participants
n=7 Participants
|
156648 Participants
n=5 Participants
|
|
Hospital admission
Yes
|
3658 Participants
n=5 Participants
|
11560 Participants
n=7 Participants
|
15218 Participants
n=5 Participants
|
|
Hospital admission
No
|
147317 Participants
n=5 Participants
|
592210 Participants
n=7 Participants
|
739527 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 years from index dateTo describe the risk of venous thromboembolism (composite of pulmonary embolism and deep vein thrombosis) in people with active AD compared to a matched control population.
Outcome measures
| Measure |
Cases
n=150975 Participants
All adults with an episode of active atopic dermatitis at any point between 1st Jan 2010 to 1st Jan 2015 will be included for analysis.
Exposure of venous thromboembolism: Composite of pulmonary embolism and deep vein thrombosis
|
Controls
n=603770 Participants
Adults without atopic dermatitis or other skin conditions matched to cases by age, gender, and duration of practice registration.
Exposure of venous thromboembolism: Composite of pulmonary embolism and deep vein thrombosis
|
|---|---|---|
|
Number of Participants With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person.
|
2576 Participants
|
7563 Participants
|
SECONDARY outcome
Timeframe: 10 years from index dateTo describe the risk of pulmonary embolism in people with active AD compared to a matched control population.
Outcome measures
| Measure |
Cases
n=150975 Participants
All adults with an episode of active atopic dermatitis at any point between 1st Jan 2010 to 1st Jan 2015 will be included for analysis.
Exposure of venous thromboembolism: Composite of pulmonary embolism and deep vein thrombosis
|
Controls
n=603770 Participants
Adults without atopic dermatitis or other skin conditions matched to cases by age, gender, and duration of practice registration.
Exposure of venous thromboembolism: Composite of pulmonary embolism and deep vein thrombosis
|
|---|---|---|
|
Number of Participants With Diagnosis of Pulmonary Embolism After the Start of Follow-up for Each Person
|
797 Participants
|
2942 Participants
|
SECONDARY outcome
Timeframe: 10 years from index dateTo describe the risk of deep-vein thrombosis in people with active AD compared to a matched control population.
Outcome measures
| Measure |
Cases
n=150975 Participants
All adults with an episode of active atopic dermatitis at any point between 1st Jan 2010 to 1st Jan 2015 will be included for analysis.
Exposure of venous thromboembolism: Composite of pulmonary embolism and deep vein thrombosis
|
Controls
n=603770 Participants
Adults without atopic dermatitis or other skin conditions matched to cases by age, gender, and duration of practice registration.
Exposure of venous thromboembolism: Composite of pulmonary embolism and deep vein thrombosis
|
|---|---|---|
|
Number of Participants With Diagnosis of Deep-vein Thrombosis After the Start of Follow-up for Each Person
|
1887 Participants
|
4934 Participants
|
SECONDARY outcome
Timeframe: 10 years from index dateTo explore the risk of VTE stratified by the male sex at the baseline in people with active AD compared to a matched control population.
Outcome measures
| Measure |
Cases
n=61882 Participants
All adults with an episode of active atopic dermatitis at any point between 1st Jan 2010 to 1st Jan 2015 will be included for analysis.
Exposure of venous thromboembolism: Composite of pulmonary embolism and deep vein thrombosis
|
Controls
n=247459 Participants
Adults without atopic dermatitis or other skin conditions matched to cases by age, gender, and duration of practice registration.
Exposure of venous thromboembolism: Composite of pulmonary embolism and deep vein thrombosis
|
|---|---|---|
|
Number of Male Participants With Diagnosis of Risk of Venous Thromboembolism After the Start of Follow-up for Each Person
|
1070 Participants
|
3170 Participants
|
SECONDARY outcome
Timeframe: 10 years from index dateTo explore the risk of VTE stratified by the female sex at the baseline in people with active AD compared to a matched control population.
Outcome measures
| Measure |
Cases
n=89093 Participants
All adults with an episode of active atopic dermatitis at any point between 1st Jan 2010 to 1st Jan 2015 will be included for analysis.
Exposure of venous thromboembolism: Composite of pulmonary embolism and deep vein thrombosis
|
Controls
n=356311 Participants
Adults without atopic dermatitis or other skin conditions matched to cases by age, gender, and duration of practice registration.
Exposure of venous thromboembolism: Composite of pulmonary embolism and deep vein thrombosis
|
|---|---|---|
|
Number of Female Participants With Diagnosis of Risk of Venous Thromboembolism After the Start of Follow-up for Each Person
|
1506 Participants
|
4393 Participants
|
SECONDARY outcome
Timeframe: 10 years from index dateTo explore the risk of VTE stratified by those aged 18-44 at the baseline in people with active AD compared to a matched control population.
Outcome measures
| Measure |
Cases
n=84253 Participants
All adults with an episode of active atopic dermatitis at any point between 1st Jan 2010 to 1st Jan 2015 will be included for analysis.
Exposure of venous thromboembolism: Composite of pulmonary embolism and deep vein thrombosis
|
Controls
n=337007 Participants
Adults without atopic dermatitis or other skin conditions matched to cases by age, gender, and duration of practice registration.
Exposure of venous thromboembolism: Composite of pulmonary embolism and deep vein thrombosis
|
|---|---|---|
|
Number of Participants Aged 18-44 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person
|
503 Participants
|
1592 Participants
|
SECONDARY outcome
Timeframe: 10 years from index dateTo explore the risk of VTE stratified by those aged 45-64 at the baseline in people with active AD compared to a matched control population.
Outcome measures
| Measure |
Cases
n=33497 Participants
All adults with an episode of active atopic dermatitis at any point between 1st Jan 2010 to 1st Jan 2015 will be included for analysis.
Exposure of venous thromboembolism: Composite of pulmonary embolism and deep vein thrombosis
|
Controls
n=133987 Participants
Adults without atopic dermatitis or other skin conditions matched to cases by age, gender, and duration of practice registration.
Exposure of venous thromboembolism: Composite of pulmonary embolism and deep vein thrombosis
|
|---|---|---|
|
Number of Participants Aged 45-64 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person
|
639 Participants
|
1858 Participants
|
SECONDARY outcome
Timeframe: 10 years from index dateTo explore the risk of VTE stratified by those aged ≥65 at the baseline in people with active AD compared to a matched control population.
Outcome measures
| Measure |
Cases
n=33225 Participants
All adults with an episode of active atopic dermatitis at any point between 1st Jan 2010 to 1st Jan 2015 will be included for analysis.
Exposure of venous thromboembolism: Composite of pulmonary embolism and deep vein thrombosis
|
Controls
n=132776 Participants
Adults without atopic dermatitis or other skin conditions matched to cases by age, gender, and duration of practice registration.
Exposure of venous thromboembolism: Composite of pulmonary embolism and deep vein thrombosis
|
|---|---|---|
|
Number of Participants Aged ≥65 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person
|
1434 Participants
|
4113 Participants
|
SECONDARY outcome
Timeframe: 10 years from index dateTo explore the risk of VTE stratified by those with a BMI \<30 at the baseline with active AD compared to a matched control population. Patients with active AD and missing BMI are excluded along with their related matched cases. Patients with active AD and no matched controls with BMI recorded are also excluded.
Outcome measures
| Measure |
Cases
n=92915 Participants
All adults with an episode of active atopic dermatitis at any point between 1st Jan 2010 to 1st Jan 2015 will be included for analysis.
Exposure of venous thromboembolism: Composite of pulmonary embolism and deep vein thrombosis
|
Controls
n=249186 Participants
Adults without atopic dermatitis or other skin conditions matched to cases by age, gender, and duration of practice registration.
Exposure of venous thromboembolism: Composite of pulmonary embolism and deep vein thrombosis
|
|---|---|---|
|
Number of Participants BMI <30 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person
|
1398 Participants
|
3188 Participants
|
SECONDARY outcome
Timeframe: 10 years from index dateTo explore the risk of VTE stratified by those with a BMI ≥30 at the baseline in people with active AD compared to a matched control population. Patients with active AD and missing BMI are excluded along with their related matched cases. Patients with active AD and no matched controls with BMI recorded are also excluded.
Outcome measures
| Measure |
Cases
n=23725 Participants
All adults with an episode of active atopic dermatitis at any point between 1st Jan 2010 to 1st Jan 2015 will be included for analysis.
Exposure of venous thromboembolism: Composite of pulmonary embolism and deep vein thrombosis
|
Controls
n=36835 Participants
Adults without atopic dermatitis or other skin conditions matched to cases by age, gender, and duration of practice registration.
Exposure of venous thromboembolism: Composite of pulmonary embolism and deep vein thrombosis
|
|---|---|---|
|
Number of Participants BMI ≥30 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person
|
685 Participants
|
760 Participants
|
SECONDARY outcome
Timeframe: 10 years from index dateTo explore the risk of VTE stratified by oestrogen contraceptive use in females aged 18-44 years at the baseline in people with active AD compared to a matched control population.
Outcome measures
| Measure |
Cases
n=4917 Participants
All adults with an episode of active atopic dermatitis at any point between 1st Jan 2010 to 1st Jan 2015 will be included for analysis.
Exposure of venous thromboembolism: Composite of pulmonary embolism and deep vein thrombosis
|
Controls
n=6925 Participants
Adults without atopic dermatitis or other skin conditions matched to cases by age, gender, and duration of practice registration.
Exposure of venous thromboembolism: Composite of pulmonary embolism and deep vein thrombosis
|
|---|---|---|
|
Number of Female Participants Aged 18-44 Using Oestrogen Contraceptive With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person
|
31 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: 10 years from index dateTo explore risk of VTE stratified by the presence, or absence of allergic conditions at baseline in people with active AD compared to a matched control population.. Allergic conditions will comprise common allergies; allergic rhinitis, allergy to dust mites or animal dander, and food allergies e.g., nut, fruit, shellfish, eggs and cows' milk allergies. Medication and other allergies will not be included.
Outcome measures
| Measure |
Cases
n=18742 Participants
All adults with an episode of active atopic dermatitis at any point between 1st Jan 2010 to 1st Jan 2015 will be included for analysis.
Exposure of venous thromboembolism: Composite of pulmonary embolism and deep vein thrombosis
|
Controls
n=25088 Participants
Adults without atopic dermatitis or other skin conditions matched to cases by age, gender, and duration of practice registration.
Exposure of venous thromboembolism: Composite of pulmonary embolism and deep vein thrombosis
|
|---|---|---|
|
Number of Participants Having History of an Allergic Condition With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person
|
193 Participants
|
203 Participants
|
Adverse Events
Cases
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place