Trial Outcomes & Findings for Low Dose Aspirin for Venous Leg Ulcers (NCT NCT02158806)
NCT ID: NCT02158806
Last Updated: 2019-01-04
Results Overview
Time to event (complete healing defined as intact skin with absence of scab)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
251 participants
Primary outcome timeframe
24 weeks
Results posted on
2019-01-04
Participant Flow
Participants were screened and recruited from five study sites in New Zealand
Enrolled participants were required to have their family physician confirm they could safely participate in the trial ie had no conditions that required treatment with aspirin and no conditions that contraindicated use of aspirin.
Participant milestones
| Measure |
Aspirin
150 mg capsule once daily for up to 24 weeks
Aspirin: 150 mg aspirin in capsule form once daily for up to 24 weeks
|
Placebo
Matching inert capsule once daily for up to 24 weeks
Placebo: Matching placebo capsule containing inert bulking agent
|
|---|---|---|
|
Overall Study
STARTED
|
125
|
126
|
|
Overall Study
COMPLETED
|
121
|
121
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
| Measure |
Aspirin
150 mg capsule once daily for up to 24 weeks
Aspirin: 150 mg aspirin in capsule form once daily for up to 24 weeks
|
Placebo
Matching inert capsule once daily for up to 24 weeks
Placebo: Matching placebo capsule containing inert bulking agent
|
|---|---|---|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
|
Overall Study
Moved out of area
|
0
|
1
|
|
Overall Study
Transferred to palliative care
|
0
|
1
|
Baseline Characteristics
Low Dose Aspirin for Venous Leg Ulcers
Baseline characteristics by cohort
| Measure |
Aspirin
n=125 Participants
150 mg capsule once daily for up to 24 weeks
Aspirin: 150 mg aspirin in capsule form once daily for up to 24 weeks
|
Placebo
n=126 Participants
Matching inert capsule once daily for up to 24 weeks
Placebo: Matching placebo capsule containing inert bulking agent
|
Total
n=251 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.1 Years
STANDARD_DEVIATION 17.1 • n=99 Participants
|
56.2 Years
STANDARD_DEVIATION 16.1 • n=107 Participants
|
58.2 Years
STANDARD_DEVIATION 16.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
118 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=99 Participants
|
68 Participants
n=107 Participants
|
133 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Māori
|
21 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Pasifika
|
23 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
NZ European/Pākehā
|
77 Participants
n=99 Participants
|
74 Participants
n=107 Participants
|
151 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Highest educational attainment
Primary school
|
9 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Highest educational attainment
Secondary school
|
66 Participants
n=99 Participants
|
74 Participants
n=107 Participants
|
140 Participants
n=206 Participants
|
|
Highest educational attainment
Undergraduate
|
9 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Highest educational attainment
Postgraduate
|
21 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Highest educational attainment
Vocational/technical
|
20 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Highest educational attainment
None
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Smoking status
Never smoked
|
62 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
125 Participants
n=206 Participants
|
|
Smoking status
Former smoker
|
47 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
91 Participants
n=206 Participants
|
|
Smoking status
Current smoker
|
16 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Medical history
Diabetes
|
13 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Medical history
Prior DVT
|
11 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Medical history
Lower limb joint replacement
|
16 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Medical history
Prior lower limb fracture
|
18 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Medical history
Prior treatment for varicosities
|
35 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
68 Participants
n=206 Participants
|
|
Ankle Brachial Index
|
1.1 Ratio of SBP ankle/SBP arm
STANDARD_DEVIATION 0.1 • n=99 Participants
|
1.1 Ratio of SBP ankle/SBP arm
STANDARD_DEVIATION 0.1 • n=107 Participants
|
1.1 Ratio of SBP ankle/SBP arm
STANDARD_DEVIATION 0.1 • n=206 Participants
|
|
Reference ulcer area
|
2.6 square centimetres
n=99 Participants
|
2.3 square centimetres
n=107 Participants
|
2.5 square centimetres
n=206 Participants
|
|
Compression system
High compression
|
105 Participants
n=99 Participants
|
102 Participants
n=107 Participants
|
207 Participants
n=206 Participants
|
|
Compression system
Light compression
|
11 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Compression system
Hosiery
|
8 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Compression system
Other
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 24 weeksTime to event (complete healing defined as intact skin with absence of scab)
Outcome measures
| Measure |
Aspirin
n=125 Participants
150 mg capsule once daily for up to 24 weeks
Aspirin: 150 mg aspirin in capsule form once daily for up to 24 weeks
|
Placebo
n=126 Participants
Matching inert capsule once daily for up to 24 weeks
Placebo: Matching placebo capsule containing inert bulking agent
|
|---|---|---|
|
Time to Complete Healing of Reference Ulcer
|
77 days
Interval 56.0 to 98.0
|
69 days
Interval 56.0 to 98.0
|
SECONDARY outcome
Timeframe: 24 weeksNumber of participants in each arm with completely healed reference ulcers at 24 weeks
Outcome measures
| Measure |
Aspirin
n=125 Participants
150 mg capsule once daily for up to 24 weeks
Aspirin: 150 mg aspirin in capsule form once daily for up to 24 weeks
|
Placebo
n=126 Participants
Matching inert capsule once daily for up to 24 weeks
Placebo: Matching placebo capsule containing inert bulking agent
|
|---|---|---|
|
Number of Participants With Healed Venous Leg Ulcers
|
88 Participants
|
101 Participants
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: Ulcer area estimated using maximum width and length of the ulcer to calculate the area of an ellipse. We have previously shown this approach to be highly correlated with digital calculation of measured area (r=0.92).
Change in estimated ulcer area from baseline to 24 weeks
Outcome measures
| Measure |
Aspirin
n=125 Participants
150 mg capsule once daily for up to 24 weeks
Aspirin: 150 mg aspirin in capsule form once daily for up to 24 weeks
|
Placebo
n=126 Participants
Matching inert capsule once daily for up to 24 weeks
Placebo: Matching placebo capsule containing inert bulking agent
|
|---|---|---|
|
Change in Estimated Ulcer Area
|
4.1 square centimetres
Standard Error 0.4
|
4.8 square centimetres
Standard Error 0.4
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: Only participants that provided both baseline and endpoint data were included in the analysis. Hence the number of participants included in this analysis is less than the number randomized.
Mean difference in change in Short Form 36 (SF36) from baseline to 24 weeks. Crude subscale scores for each group are not shown (each crude subscale is scored 0 to 100 at baseline and 24 weeks); higher mean differences in change from baseline to 24 weeks within groups indicate greater change on the subscales for that group.
Outcome measures
| Measure |
Aspirin
n=116 Participants
150 mg capsule once daily for up to 24 weeks
Aspirin: 150 mg aspirin in capsule form once daily for up to 24 weeks
|
Placebo
n=115 Participants
Matching inert capsule once daily for up to 24 weeks
Placebo: Matching placebo capsule containing inert bulking agent
|
|---|---|---|
|
Change in Health-related Quality of Life (Short Form 36)
Physical Functioning
|
5.0 units on a scale
Standard Error 2.2
|
3.8 units on a scale
Standard Error 2.2
|
|
Change in Health-related Quality of Life (Short Form 36)
Role Physical
|
11.7 units on a scale
Standard Error 3.4
|
10.3 units on a scale
Standard Error 3.4
|
|
Change in Health-related Quality of Life (Short Form 36)
Bodily Pain
|
11.4 units on a scale
Standard Error 2.2
|
9.0 units on a scale
Standard Error 2.2
|
|
Change in Health-related Quality of Life (Short Form 36)
General Health
|
-1.1 units on a scale
Standard Error 1.4
|
-0.8 units on a scale
Standard Error 1.4
|
|
Change in Health-related Quality of Life (Short Form 36)
Vitality
|
3.9 units on a scale
Standard Error 1.6
|
-0.3 units on a scale
Standard Error 1.6
|
|
Change in Health-related Quality of Life (Short Form 36)
Social Functioning
|
5.8 units on a scale
Standard Error 2.2
|
4.9 units on a scale
Standard Error 2.2
|
|
Change in Health-related Quality of Life (Short Form 36)
Role Emotional
|
10.5 units on a scale
Standard Error 3.1
|
6.8 units on a scale
Standard Error 3.1
|
|
Change in Health-related Quality of Life (Short Form 36)
Mental Health
|
-1.2 units on a scale
Standard Error 1.4
|
1.2 units on a scale
Standard Error 1.4
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: Only participants that provided both baseline and endpoint data were included in the analysis. Hence the number of participants included in this analysis is less than the number randomised.
Mean difference in change measured by EuroQol 5D (EQ5D 3L) from baseline to 24 weeks. Crude health state scores for each group are not shown (health state is scored 0 to 100 at baseline and 24 weeks); higher mean differences in change from baseline to 24 weeks within groups indicate greater change on health state for that group.
Outcome measures
| Measure |
Aspirin
n=116 Participants
150 mg capsule once daily for up to 24 weeks
Aspirin: 150 mg aspirin in capsule form once daily for up to 24 weeks
|
Placebo
n=115 Participants
Matching inert capsule once daily for up to 24 weeks
Placebo: Matching placebo capsule containing inert bulking agent
|
|---|---|---|
|
Change in Health-related Quality of Life (EuroQol-5D 3L)
|
7.4 score on a scale
Standard Error 1.6
|
4.0 score on a scale
Standard Error 1.7
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Only participants that provided both baseline and endpoint data were included in the analysis. Hence the number of participants included in this analysis is less than the number randomised.
Mean difference in change in Charing Cross Venous Ulcer Questionnaire (CXVUQ)) from baseline to 24 weeks. Crude subscale scores for each group are not shown (each crude subscale is scored 0 to 100 at baseline and 24 weeks); higher mean differences in change from baseline to 24 weeks within groups indicate greater change on the subscales for that group.
Outcome measures
| Measure |
Aspirin
n=115 Participants
150 mg capsule once daily for up to 24 weeks
Aspirin: 150 mg aspirin in capsule form once daily for up to 24 weeks
|
Placebo
n=116 Participants
Matching inert capsule once daily for up to 24 weeks
Placebo: Matching placebo capsule containing inert bulking agent
|
|---|---|---|
|
Change in Health-related Quality of Life (Charing Cross Venous Ulcer Questionnaire)
Social function
|
-6.2 score on a scale
Standard Error 1.3
|
-4.7 score on a scale
Standard Error 1.3
|
|
Change in Health-related Quality of Life (Charing Cross Venous Ulcer Questionnaire)
Domestic activities
|
-6.6 score on a scale
Standard Error 1.1
|
-5.2 score on a scale
Standard Error 1.2
|
|
Change in Health-related Quality of Life (Charing Cross Venous Ulcer Questionnaire)
Cosmesis
|
-6.1 score on a scale
Standard Error 1.6
|
-4.9 score on a scale
Standard Error 1.6
|
|
Change in Health-related Quality of Life (Charing Cross Venous Ulcer Questionnaire)
Emotional status
|
-9.4 score on a scale
Standard Error 1.8
|
-6.5 score on a scale
Standard Error 1.8
|
|
Change in Health-related Quality of Life (Charing Cross Venous Ulcer Questionnaire)
Overall
|
-7.3 score on a scale
Standard Error 1.2
|
-5.5 score on a scale
Standard Error 1.2
|
SECONDARY outcome
Timeframe: 24 weeksAdherence to study medication as measured by pill counts (agreement between expected number of tablets remaining after healing and days to healing)
Outcome measures
| Measure |
Aspirin
n=125 Participants
150 mg capsule once daily for up to 24 weeks
Aspirin: 150 mg aspirin in capsule form once daily for up to 24 weeks
|
Placebo
n=126 Participants
Matching inert capsule once daily for up to 24 weeks
Placebo: Matching placebo capsule containing inert bulking agent
|
|---|---|---|
|
Number of Participants With Adherence to Treatment
|
92 Participants
|
92 Participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Only participants that reported any reported untoward medical event were included in this analysis.
Total number of different types of adverse events in participants who reported with any untoward medical event
Outcome measures
| Measure |
Aspirin
n=40 Number of events
150 mg capsule once daily for up to 24 weeks
Aspirin: 150 mg aspirin in capsule form once daily for up to 24 weeks
|
Placebo
n=37 Number of events
Matching inert capsule once daily for up to 24 weeks
Placebo: Matching placebo capsule containing inert bulking agent
|
|---|---|---|
|
Incidence of Adverse Events at 24 Weeks
Cancer
|
6 Number of events
|
1 Number of events
|
|
Incidence of Adverse Events at 24 Weeks
Cardiovascular
|
0 Number of events
|
4 Number of events
|
|
Incidence of Adverse Events at 24 Weeks
Gastrointestinal
|
8 Number of events
|
4 Number of events
|
|
Incidence of Adverse Events at 24 Weeks
Respiratory
|
3 Number of events
|
0 Number of events
|
|
Incidence of Adverse Events at 24 Weeks
Genitourinary
|
2 Number of events
|
0 Number of events
|
|
Incidence of Adverse Events at 24 Weeks
Skin & cutaneous
|
1 Number of events
|
5 Number of events
|
|
Incidence of Adverse Events at 24 Weeks
Accidental injury
|
4 Number of events
|
4 Number of events
|
|
Incidence of Adverse Events at 24 Weeks
Psychiatric
|
1 Number of events
|
0 Number of events
|
|
Incidence of Adverse Events at 24 Weeks
Signs & symptoms
|
7 Number of events
|
5 Number of events
|
|
Incidence of Adverse Events at 24 Weeks
Leg ulcer bleeding
|
2 Number of events
|
2 Number of events
|
|
Incidence of Adverse Events at 24 Weeks
Leg ulcer infection
|
2 Number of events
|
4 Number of events
|
|
Incidence of Adverse Events at 24 Weeks
Extension of leg ulcer
|
1 Number of events
|
2 Number of events
|
|
Incidence of Adverse Events at 24 Weeks
New leg ulcer
|
1 Number of events
|
3 Number of events
|
|
Incidence of Adverse Events at 24 Weeks
Other
|
2 Number of events
|
3 Number of events
|
Adverse Events
Aspirin
Serious events: 11 serious events
Other events: 20 other events
Deaths: 2 deaths
Placebo
Serious events: 10 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aspirin
n=125 participants at risk
150 mg capsule once daily for up to 24 weeks
Aspirin: 150 mg aspirin in capsule form once daily for up to 24 weeks
|
Placebo
n=126 participants at risk
Matching inert capsule once daily for up to 24 weeks
Placebo: Matching placebo capsule containing inert bulking agent
|
|---|---|---|
|
Infections and infestations
Hospitalisation or prolongation of hospitalisation
|
0.80%
1/125 • Number of events 1 • 24 weeks
|
2.4%
3/126 • Number of events 3 • 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hospitalisation or prolongation of hospitalisation
|
0.80%
1/125 • Number of events 2 • 24 weeks
|
0.00%
0/126 • 24 weeks
|
|
Cardiac disorders
Hospitalisation or prolongation of hospitalisation
|
0.00%
0/125 • 24 weeks
|
0.79%
1/126 • Number of events 1 • 24 weeks
|
|
Blood and lymphatic system disorders
Hospitalisation or prolongation of hospitalisation
|
0.80%
1/125 • Number of events 1 • 24 weeks
|
0.00%
0/126 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalisation or prolongation of hospitalisation
|
0.80%
1/125 • Number of events 1 • 24 weeks
|
0.00%
0/126 • 24 weeks
|
|
Gastrointestinal disorders
Hospitalisation or prolongation of hospitalisation
|
0.80%
1/125 • Number of events 1 • 24 weeks
|
0.00%
0/126 • 24 weeks
|
|
Renal and urinary disorders
Hospitalisation or prolongation of hospitalisation
|
0.80%
1/125 • Number of events 1 • 24 weeks
|
0.00%
0/126 • 24 weeks
|
|
General disorders
Hospitalisation or prolongation of hospitalisation
|
0.80%
1/125 • Number of events 2 • 24 weeks
|
0.00%
0/126 • 24 weeks
|
|
Injury, poisoning and procedural complications
Hospitalisation or prolongation of hospitalisation
|
0.00%
0/125 • 24 weeks
|
0.79%
1/126 • Number of events 1 • 24 weeks
|
|
Surgical and medical procedures
Hospitalisation or prolongation of hospitalisation
|
0.80%
1/125 • Number of events 1 • 24 weeks
|
0.00%
0/126 • 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Life threatening event of illness
|
0.00%
0/125 • 24 weeks
|
0.79%
1/126 • Number of events 1 • 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Significan medical event
|
1.6%
2/125 • Number of events 2 • 24 weeks
|
0.00%
0/126 • 24 weeks
|
|
Immune system disorders
Significant medical event
|
0.00%
0/125 • 24 weeks
|
0.79%
1/126 • Number of events 1 • 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death
|
0.80%
1/125 • Number of events 1 • 24 weeks
|
0.00%
0/126 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Death
|
0.80%
1/125 • Number of events 1 • 24 weeks
|
0.00%
0/126 • 24 weeks
|
Other adverse events
| Measure |
Aspirin
n=125 participants at risk
150 mg capsule once daily for up to 24 weeks
Aspirin: 150 mg aspirin in capsule form once daily for up to 24 weeks
|
Placebo
n=126 participants at risk
Matching inert capsule once daily for up to 24 weeks
Placebo: Matching placebo capsule containing inert bulking agent
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract infection
|
0.80%
1/125 • Number of events 1 • 24 weeks
|
0.00%
0/126 • 24 weeks
|
|
Blood and lymphatic system disorders
Bleeding from any lower leg ulceration
|
1.6%
2/125 • Number of events 2 • 24 weeks
|
1.6%
2/126 • Number of events 2 • 24 weeks
|
|
Infections and infestations
Infection of ulceration, any lower leg ulceration
|
0.80%
1/125 • Number of events 1 • 24 weeks
|
2.4%
3/126 • Number of events 4 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Developed any new lower leg ulceration
|
0.80%
1/125 • Number of events 1 • 24 weeks
|
2.4%
3/126 • Number of events 3 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Extension of reference ulceration
|
0.80%
1/125 • Number of events 1 • 24 weeks
|
1.6%
2/126 • Number of events 2 • 24 weeks
|
|
Infections and infestations
Candidal stomatitis
|
0.00%
0/125 • 24 weeks
|
0.79%
1/126 • Number of events 1 • 24 weeks
|
|
Blood and lymphatic system disorders
Coagulation defect, unspecified
|
0.80%
1/125 • Number of events 1 • 24 weeks
|
0.00%
0/126 • 24 weeks
|
|
Psychiatric disorders
Depressive episode, unspecified
|
0.80%
1/125 • Number of events 1 • 24 weeks
|
0.00%
0/126 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Acute inflammation of orbit
|
0.80%
1/125 • Number of events 1 • 24 weeks
|
0.00%
0/126 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Varicose veins of lower extremities with inflammation
|
0.00%
0/125 • 24 weeks
|
0.79%
1/126 • Number of events 1 • 24 weeks
|
|
Vascular disorders
Varicose veins of lower extremities without ulcer or inflammation
|
0.00%
0/125 • 24 weeks
|
0.79%
1/126 • Number of events 1 • 24 weeks
|
|
Gastrointestinal disorders
Gastro-oesophageal reflux disease without oesophagi's
|
0.80%
1/125 • Number of events 1 • 24 weeks
|
0.00%
0/126 • 24 weeks
|
|
Gastrointestinal disorders
Gastric ulcer, unspecified as acute or chronic, without haemorrhage or perforation
|
0.80%
1/125 • Number of events 1 • 24 weeks
|
0.00%
0/126 • 24 weeks
|
|
Gastrointestinal disorders
Gastritis, unspecified
|
1.6%
2/125 • Number of events 2 • 24 weeks
|
0.79%
1/126 • Number of events 1 • 24 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
0.80%
1/125 • Number of events 1 • 24 weeks
|
0.00%
0/126 • 24 weeks
|
|
Gastrointestinal disorders
Functional diarrhoea
|
0.00%
0/125 • 24 weeks
|
0.79%
1/126 • Number of events 1 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Cellulitis of lower limb
|
0.00%
0/125 • 24 weeks
|
1.6%
2/126 • Number of events 2 • 24 weeks
|
|
Renal and urinary disorders
Urinary tract infection, site not specified
|
0.80%
1/125 • Number of events 1 • 24 weeks
|
0.00%
0/126 • 24 weeks
|
|
Blood and lymphatic system disorders
Epistaxis
|
0.80%
1/125 • Number of events 1 • 24 weeks
|
0.00%
0/126 • 24 weeks
|
|
Gastrointestinal disorders
Nausea and vomiting
|
1.6%
2/125 • Number of events 2 • 24 weeks
|
0.79%
1/126 • Number of events 1 • 24 weeks
|
|
Injury, poisoning and procedural complications
Tendency to fall, not elsewhere classified
|
0.00%
0/125 • 24 weeks
|
0.79%
1/126 • Number of events 1 • 24 weeks
|
|
General disorders
Hyperhidrosis
|
0.00%
0/125 • 24 weeks
|
0.79%
1/126 • Number of events 1 • 24 weeks
|
|
Injury, poisoning and procedural complications
Laceration and contusions
|
3.2%
4/125 • Number of events 4 • 24 weeks
|
0.79%
1/126 • Number of events 1 • 24 weeks
|
|
Immune system disorders
Allergy, unspecified
|
0.00%
0/125 • 24 weeks
|
0.79%
1/126 • Number of events 1 • 24 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place