Trial Outcomes & Findings for WILL lOWer Dose Aspirin be Better With Rivaroxaban in Patients With Chronic Coronary Syndromes? (NCT NCT04990791)
NCT ID: NCT04990791
Last Updated: 2026-02-20
Results Overview
The primary endpoint will be difference in bleeding time, measured at 2 hours post-dose, assessed between aspirin (aspirin lysine) 75 mg once-daily alone vs. aspirin (aspirin lysine) 20 mg twice-daily plus rivaroxaban 2.5 mg twice-daily and aspirin (aspirin lysine) 75 mg once-daily alone vs. aspirin (aspirin lysine) 75 mg once-daily plus rivaroxaban 2.5 mg twice-daily.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
48 participants
Primary outcome timeframe
after 14(-2) days on each treatment schedule, bleeding time (seconds) performed 2 hours after the latest dose of aspirin +/- rivaroxaban.
Results posted on
2026-02-20
Participant Flow
Participants were randomly assigned one of two treatment schedules: 1) 75mg aspirin once daily for 10-14 days followed by 75mg aspirin once daily PLUS 2.5mg rivaroxaban twice daily for 10-14days followed by 20mg aspirin twice daily plus 2.5mg rivaroxaban twice daily for 10-14days. OR 2) 75mg aspirin once daily for 10-14days followed by 20mg aspirin twice daily PLUS 2.5mg rivaroxaban twice daily for 10-14 days followed by 75mg aspirin once daily plus 2.5mg rivaroxaban twice daily for 10-14 days
Participant milestones
| Measure |
Aspirin 75 mg OD, Aspirin 75mg OD +Rivaroxaban 2.5mg BD, Aspirin 20mg BD + Rivaroxaban 2.5mg BD
Aspirin 75mg was administered to participants once a day for two weeks, followed by aspirin 75mg OD + rivaroxaban 2.5mg BD for two weeks then aspirin 20mg BD + rivaroxaban 2.5mg BD for two weeks. Blood samples and bleeding time was tested before and after the final dose of eachtwo week period.
|
Aspirin 75mg OD, Aspirin 20mg BD Plus+ Rivaroxaban 2.5mg BD, Aspirin 75mg OD + Rivaroxaban 2.5mg BD
Aspirin 75mg was administered to participants once a day for two weeks, followed by aspirin 20mg BD + rivaroxaban 2.5mg BD for two weeks then aspirin 75mg OD + rivaroxaban 2.5mg BD for two weeks. Blood samples and bleeding time was tested before and after the final dose of each two week period.
|
|---|---|---|
|
Period 1
STARTED
|
24
|
22
|
|
Period 1
COMPLETED
|
24
|
22
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
22
|
21
|
|
Period 2
COMPLETED
|
22
|
21
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
|
Period 3
STARTED
|
22
|
20
|
|
Period 3
COMPLETED
|
22
|
20
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
WILL lOWer Dose Aspirin be Better With Rivaroxaban in Patients With Chronic Coronary Syndromes?
Baseline characteristics by cohort
| Measure |
Aspirin 75 mg OD, Aspirin 75mg OD +Rivaroxaban 2.5mg BD, Aspirin 20mg BD + Rivaroxaban 2.5mg BD
n=24 Participants
75mg aspirin once daily for 10-14 days followed by 75mg aspirin once daily PLUS 2.5mg rivaroxaban twice daily for 10-14days followed by 20mg aspirin twice daily plus 2.5mg rivaroxaban twice daily for 10-14days.
Blood samples and bleeding time was tested before and after the final dose of each two week period.
|
Aspirin 75 mg OD, Aspirin 20mg BD + Rivaroxaban 2.5mg BD, Aspirin 75mg OD + Rivaroxaban 2.5mg BD
n=22 Participants
75mg aspirin once daily for 10-14days followed by 20mg aspirin twice daily PLUS 2.5mg rivaroxaban twice daily for 10-14 days followed by 75mg aspirin once daily plus 2.5mg rivaroxaban twice daily for 10-14 days. Blood samples and bleeding time was tested before and after the final dose of each two week period.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=29 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=29 Participants
|
|
Age, Categorical
>=65 years
|
24 Participants
n=14 Participants
|
22 Participants
n=14 Participants
|
46 Participants
n=29 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=14 Participants
|
4 Participants
n=14 Participants
|
6 Participants
n=29 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=14 Participants
|
18 Participants
n=14 Participants
|
40 Participants
n=29 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
1 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=29 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=14 Participants
|
22 Participants
n=14 Participants
|
45 Participants
n=29 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=29 Participants
|
PRIMARY outcome
Timeframe: after 14(-2) days on each treatment schedule, bleeding time (seconds) performed 2 hours after the latest dose of aspirin +/- rivaroxaban.Population: intention to treat
The primary endpoint will be difference in bleeding time, measured at 2 hours post-dose, assessed between aspirin (aspirin lysine) 75 mg once-daily alone vs. aspirin (aspirin lysine) 20 mg twice-daily plus rivaroxaban 2.5 mg twice-daily and aspirin (aspirin lysine) 75 mg once-daily alone vs. aspirin (aspirin lysine) 75 mg once-daily plus rivaroxaban 2.5 mg twice-daily.
Outcome measures
| Measure |
Aspirin 75 mg Once a Day
n=46 Participants
Aspirin 75mg was administered to participants once a day for two weeks. Blood samples and bleeding time was tested before and after the final dose of the two week period.
|
Aspirin 75 mg Once a Day Plus Rivaroxaban 2.5 mg Twice Daily
n=43 Participants
Aspirin 75mg once daily and rivaroxaban 2.5mg twice daily were administered to participants for two weeks. Blood samples and bleeding time was tested before and after the final dose of the two week period.
|
Aspirin 20 mg Twice Daily Plus Rivaroxaban 2.5 mg Twice Daily
n=42 Participants
Aspirin 20 mg twice daily plus rivaroxaban 2.5 mg twice daily was administered to each participant for two weeks. Blood samples and bleeding time test were done before and after the final dose of the two week period.
|
|---|---|---|---|
|
Bleeding Time Difference
|
0 s
Standard Deviation 0
|
75 s
Standard Deviation 217
|
-15 s
Standard Deviation 158
|
Adverse Events
Aspirin 75 mg Once a Day
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Aspirin 75 mg Once a Day Plus Rivaroxaban 2.5 mg Twice Daily
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Aspirin 20 mg Twice Daily Plus Rivaroxaban 2.5 mg Twice Daily
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aspirin 75 mg Once a Day
n=46 participants at risk
Aspirin 75mg was administered to participants once a day for two weeks. Blood samples and bleeding time was tested before and after the final dose of the two week period.
|
Aspirin 75 mg Once a Day Plus Rivaroxaban 2.5 mg Twice Daily
n=43 participants at risk
Aspirin 75mg once daily and rivaroxaban 2.5mg twice daily were administered to participants for two weeks. Blood samples and bleeding time was tested before and after the final dose of the two week period.
|
Aspirin 20 mg Twice Daily Plus Rivaroxaban 2.5 mg Twice Daily
n=42 participants at risk
Aspirin 20 mg twice daily plus rivaroxaban 2.5 mg twice daily was administered to each participant for two weeks. Blood samples and bleeding time test were done before and after the final dose of the two week period.
|
|---|---|---|---|
|
Cardiac disorders
NSTEMI
|
0.00%
0/46 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
2.3%
1/43 • Number of events 1 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/42 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
Other adverse events
| Measure |
Aspirin 75 mg Once a Day
n=46 participants at risk
Aspirin 75mg was administered to participants once a day for two weeks. Blood samples and bleeding time was tested before and after the final dose of the two week period.
|
Aspirin 75 mg Once a Day Plus Rivaroxaban 2.5 mg Twice Daily
n=43 participants at risk
Aspirin 75mg once daily and rivaroxaban 2.5mg twice daily were administered to participants for two weeks. Blood samples and bleeding time was tested before and after the final dose of the two week period.
|
Aspirin 20 mg Twice Daily Plus Rivaroxaban 2.5 mg Twice Daily
n=42 participants at risk
Aspirin 20 mg twice daily plus rivaroxaban 2.5 mg twice daily was administered to each participant for two weeks. Blood samples and bleeding time test were done before and after the final dose of the two week period.
|
|---|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
6.5%
3/46 • Number of events 3 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
2.3%
1/43 • Number of events 1 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/42 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
|
Reproductive system and breast disorders
Elevated PSA
|
2.2%
1/46 • Number of events 1 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/43 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/42 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
|
Investigations
Low ferritin
|
0.00%
0/46 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/43 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
2.4%
1/42 • Number of events 1 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
|
Cardiac disorders
Angina
|
4.3%
2/46 • Number of events 2 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/43 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/42 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
|
Injury, poisoning and procedural complications
Wasp sting
|
2.2%
1/46 • Number of events 1 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/43 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/42 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
|
Injury, poisoning and procedural complications
Nose bleed
|
4.3%
2/46 • Number of events 2 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/43 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
4.8%
2/42 • Number of events 2 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
|
Investigations
Weight loss
|
0.00%
0/46 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/43 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
2.4%
1/42 • Number of events 1 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
|
Injury, poisoning and procedural complications
Grazed Knee
|
2.2%
1/46 • Number of events 1 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/43 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/42 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
|
General disorders
Allergy
|
2.2%
1/46 • Number of events 1 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/43 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/42 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.2%
1/46 • Number of events 1 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/43 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/42 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
|
Blood and lymphatic system disorders
Microcytosis
|
2.2%
1/46 • Number of events 1 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/43 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/42 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
|
Metabolism and nutrition disorders
Iron Deficiency
|
2.2%
1/46 • Number of events 1 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/43 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/42 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
|
General disorders
Bilateral leg swelling
|
2.2%
1/46 • Number of events 1 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/43 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/42 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
|
Cardiac disorders
Syncope
|
2.2%
1/46 • Number of events 1 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/43 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/42 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
URTI
|
2.2%
1/46 • Number of events 1 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
2.3%
1/43 • Number of events 1 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
4.8%
2/42 • Number of events 2 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
|
Injury, poisoning and procedural complications
Minor bleeding
|
2.2%
1/46 • Number of events 1 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
2.3%
1/43 • Number of events 1 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/42 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
|
Injury, poisoning and procedural complications
Minor bruising
|
2.2%
1/46 • Number of events 1 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/43 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
4.8%
2/42 • Number of events 2 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
|
General disorders
Headache
|
4.3%
2/46 • Number of events 2 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/43 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/42 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Leg cramps
|
2.2%
1/46 • Number of events 1 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
2.3%
1/43 • Number of events 1 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/42 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.2%
1/46 • Number of events 1 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/43 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/42 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/46 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
2.3%
1/43 • Number of events 1 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/42 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
|
Metabolism and nutrition disorders
gout
|
0.00%
0/46 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
2.3%
1/43 • Number of events 1 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/42 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/46 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
2.3%
1/43 • Number of events 1 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/42 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
|
Ear and labyrinth disorders
Obstruction of eustachian tube
|
0.00%
0/46 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
2.3%
1/43 • Number of events 1 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/42 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
|
Gastrointestinal disorders
Mild Gastritis
|
0.00%
0/46 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
2.3%
1/43 • Number of events 1 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/42 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
|
Cardiac disorders
Hypertension and Bradycardia
|
0.00%
0/46 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
2.3%
1/43 • Number of events 1 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/42 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/46 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
2.3%
1/43 • Number of events 1 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/42 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/46 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/43 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
2.4%
1/42 • Number of events 1 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
|
General disorders
gingival bleeding
|
0.00%
0/46 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/43 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
2.4%
1/42 • Number of events 1 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
|
General disorders
Tiredness
|
0.00%
0/46 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/43 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
2.4%
1/42 • Number of events 1 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
0.00%
0/46 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/43 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
2.4%
1/42 • Number of events 1 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
|
General disorders
Swollen hands and face
|
0.00%
0/46 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/43 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
2.4%
1/42 • Number of events 1 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Aching in limb
|
0.00%
0/46 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/43 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
2.4%
1/42 • Number of events 1 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
|
Cardiac disorders
Non-ST Segment Elevation Myocardial Infarction
|
0.00%
0/46 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/43 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
2.4%
1/42 • Number of events 1 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
|
General disorders
Malaise
|
0.00%
0/46 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/43 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
2.4%
1/42 • Number of events 1 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
|
Gastrointestinal disorders
Oral discomfort
|
0.00%
0/46 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/43 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
2.4%
1/42 • Number of events 1 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
|
Cardiac disorders
Mild Aortic Stenosis
|
0.00%
0/46 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/43 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
2.4%
1/42 • Number of events 1 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
|
Immune system disorders
insect bite allergy
|
0.00%
0/46 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
0.00%
0/43 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
2.4%
1/42 • Number of events 1 • Duration of study participation from date of randomisation until 8 weeks post randomisation. Events recorded after each treatment period of 14 (-2) days.
Protocol specified definitions of adverse and serious adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place