Trial Outcomes & Findings for Naproxen Sodium/ASA Platelet Study (NCT NCT02229461)
NCT ID: NCT02229461
Last Updated: 2016-07-15
Results Overview
Inhibition of serum TXB2 at specified time point was calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value - Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% Confidence Interval (CI) were calculated.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
117 participants
Primary outcome timeframe
At hour 24 on Day 16 post treatment
Results posted on
2016-07-15
Participant Flow
The study was conducted at a single site in United States between 16-Feb-2015 (first patient first visit) and 08-May-2015 (last patient last visit).
Of 117 screened participants in Run-In period, 15 were not randomized into Treatment Period. 2 participants were not randomized because of non-compliance; 3 because of investigator's decision; the other 10 because of other reasons (e.g arachidonic acid-induced platelet aggregation≥20% or pre-randomization elimination of back-up participants).
Participant milestones
| Measure |
Group 1-IR ASA Co-administered With Naproxen Sodium
Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
|
Group 2-IR ASA 30 Min After Naproxen Sodium
Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
|
Group 3-IR ASA 8 Hours After Naproxen Sodium
Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
|
Group 4-IR ASA Only
Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.
|
Group 5-IR ASA 30 Min Before Naproxen Sodium
Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
|
Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid
Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
17
|
17
|
17
|
17
|
|
Overall Study
COMPLETED
|
17
|
17
|
17
|
17
|
17
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Naproxen Sodium/ASA Platelet Study
Baseline characteristics by cohort
| Measure |
Group 1-IR ASA Co-administered With Naproxen Sodium
n=17 Participants
Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
|
Group 2-IR ASA 30 Min After Naproxen Sodium
n=17 Participants
Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
|
Group 3-IR ASA 8 Hours After Naproxen Sodium
n=17 Participants
Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
|
Group 4-IR ASA Only
n=17 Participants
Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.
|
Group 5-IR ASA 30 Min Before Naproxen Sodium
n=17 Participants
Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
|
Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid
n=17 Participants
Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
|
Non-Randomized
n=15 Participants
Fifteen participants were not randomized into Treatment Period.
|
Total
n=117 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
41.3 years
STANDARD_DEVIATION 8.46 • n=5 Participants
|
31.2 years
STANDARD_DEVIATION 7.19 • n=7 Participants
|
37.5 years
STANDARD_DEVIATION 13.41 • n=5 Participants
|
34.2 years
STANDARD_DEVIATION 8.76 • n=4 Participants
|
38.8 years
STANDARD_DEVIATION 12.09 • n=21 Participants
|
38.9 years
STANDARD_DEVIATION 10.62 • n=10 Participants
|
38.2 years
STANDARD_DEVIATION 13.74 • n=115 Participants
|
37.1 years
STANDARD_DEVIATION 11.00 • n=24 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
36 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
81 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: At hour 24 on Day 16 post treatmentPopulation: Percentages are based on the number of participants in the Evaluable Population in each treatment group.
Inhibition of serum TXB2 at specified time point was calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value - Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% Confidence Interval (CI) were calculated.
Outcome measures
| Measure |
Group 1-IR ASA Co-administered With Naproxen Sodium
n=13 Participants
Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
|
Group 2-IR ASA 30 Min After Naproxen Sodium
n=14 Participants
Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
|
Group 3-IR ASA 8 Hours After Naproxen Sodium
n=15 Participants
Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
|
Group 4-IR ASA Only
n=13 Participants
Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.
|
Group 5-IR ASA 30 Min Before Naproxen Sodium
n=10 Participants
Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
|
Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid
n=15 Participants
Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
|
|---|---|---|---|---|---|---|
|
Inhibition of Serum Thromboxane B2 (TXB2) on Day 16 at 24 Hour Post IR ASA 81 mg Administration
|
93.09 percentage
Interval 91.5 to
One-sided 95% CI
|
87.71 percentage
Interval 85.51 to
One-sided 95% CI
|
92.87 percentage
Interval 91.24 to
One-sided 95% CI
|
98.72 percentage
Interval 98.49 to
One-sided 95% CI
|
95.35 percentage
Interval 94.14 to
One-sided 95% CI
|
95.65 percentage
Interval 94.74 to
One-sided 95% CI
|
SECONDARY outcome
Timeframe: At 1, 3, 6, 12, 18, and 24 hours on Days 7, 16, 17, and 19 (except 24 hours on Day 16)Population: Percentages are based on the number of participants in the Evaluable Population in each treatment group.
Inhibition of serum TXB2 at each time point were calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value - Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% CI were calculated.
Outcome measures
| Measure |
Group 1-IR ASA Co-administered With Naproxen Sodium
n=13 Participants
Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
|
Group 2-IR ASA 30 Min After Naproxen Sodium
n=14 Participants
Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
|
Group 3-IR ASA 8 Hours After Naproxen Sodium
n=15 Participants
Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
|
Group 4-IR ASA Only
n=13 Participants
Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.
|
Group 5-IR ASA 30 Min Before Naproxen Sodium
n=10 Participants
Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
|
Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid
n=15 Participants
Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
|
|---|---|---|---|---|---|---|
|
Inhibition of Serum TXB2 on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours (Except at 24 Hours on Day 16) Post IR ASA 81 mg Administration
Day 19 at 24 hour
|
97.04 percentage
Interval 96.13 to
One-sided 95% CI
|
96.16 percentage
Interval 95.25 to
One-sided 95% CI
|
97.98 percentage
Interval 97.72 to
One-sided 95% CI
|
98.49 percentage
Interval 98.19 to
One-sided 95% CI
|
96.01 percentage
Interval 94.86 to
One-sided 95% CI
|
90.67 percentage
Interval 88.25 to
One-sided 95% CI
|
|
Inhibition of Serum TXB2 on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours (Except at 24 Hours on Day 16) Post IR ASA 81 mg Administration
Day 7 at 1 hour
|
99.86 percentage
Interval 99.82 to
One-sided 95% CI
|
99.83 percentage
Interval 99.81 to
One-sided 95% CI
|
99.69 percentage
Interval 99.63 to
One-sided 95% CI
|
99.67 percentage
Interval 99.6 to
One-sided 95% CI
|
99.91 percentage
Interval 99.87 to
One-sided 95% CI
|
99.84 percentage
Interval 99.81 to
One-sided 95% CI
|
|
Inhibition of Serum TXB2 on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours (Except at 24 Hours on Day 16) Post IR ASA 81 mg Administration
Day 7 at 3 hour
|
99.84 percentage
Interval 99.79 to
One-sided 95% CI
|
99.79 percentage
Interval 99.76 to
One-sided 95% CI
|
99.54 percentage
Interval 99.46 to
One-sided 95% CI
|
99.66 percentage
Interval 99.58 to
One-sided 95% CI
|
99.86 percentage
Interval 99.81 to
One-sided 95% CI
|
99.80 percentage
Interval 99.77 to
One-sided 95% CI
|
|
Inhibition of Serum TXB2 on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours (Except at 24 Hours on Day 16) Post IR ASA 81 mg Administration
Day 7 at 6 hour
|
99.69 percentage
Interval 99.58 to
One-sided 95% CI
|
99.67 percentage
Interval 99.6 to
One-sided 95% CI
|
99.44 percentage
Interval 99.34 to
One-sided 95% CI
|
99.48 percentage
Interval 99.36 to
One-sided 95% CI
|
99.75 percentage
Interval 99.63 to
One-sided 95% CI
|
99.70 percentage
Interval 99.65 to
One-sided 95% CI
|
|
Inhibition of Serum TXB2 on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours (Except at 24 Hours on Day 16) Post IR ASA 81 mg Administration
Day 7 at 12 hour
|
99.59 percentage
Interval 99.46 to
One-sided 95% CI
|
99.48 percentage
Interval 99.42 to
One-sided 95% CI
|
99.12 percentage
Interval 98.98 to
One-sided 95% CI
|
99.31 percentage
Interval 99.17 to
One-sided 95% CI
|
99.68 percentage
Interval 99.57 to
One-sided 95% CI
|
99.63 percentage
Interval 99.56 to
One-sided 95% CI
|
|
Inhibition of Serum TXB2 on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours (Except at 24 Hours on Day 16) Post IR ASA 81 mg Administration
Day 7 at 18 hour
|
99.18 percentage
Interval 99.01 to
One-sided 95% CI
|
99.18 percentage
Interval 99.04 to
One-sided 95% CI
|
99.76 percentage
Interval 99.71 to
One-sided 95% CI
|
98.86 percentage
Interval 98.68 to
One-sided 95% CI
|
99.39 percentage
Interval 99.19 to
One-sided 95% CI
|
99.70 percentage
Interval 99.64 to
One-sided 95% CI
|
|
Inhibition of Serum TXB2 on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours (Except at 24 Hours on Day 16) Post IR ASA 81 mg Administration
Day 7 at 24 hour
|
99.01 percentage
Interval 98.76 to
One-sided 95% CI
|
99.55 percentage
Interval 99.43 to
One-sided 95% CI
|
97.78 percentage
Interval 96.51 to
One-sided 95% CI
|
98.71 percentage
Interval 98.46 to
One-sided 95% CI
|
99.23 percentage
Interval 99.0 to
One-sided 95% CI
|
99.80 percentage
Interval 99.75 to
One-sided 95% CI
|
|
Inhibition of Serum TXB2 on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours (Except at 24 Hours on Day 16) Post IR ASA 81 mg Administration
Day 16 at 1 hour
|
99.06 percentage
Interval 98.79 to
One-sided 95% CI
|
98.38 percentage
Interval 98.1 to
One-sided 95% CI
|
98.32 percentage
Interval 98.09 to
One-sided 95% CI
|
99.71 percentage
Interval 99.64 to
One-sided 95% CI
|
99.28 percentage
Interval 99.08 to
One-sided 95% CI
|
98.81 percentage
Interval 98.59 to
One-sided 95% CI
|
|
Inhibition of Serum TXB2 on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours (Except at 24 Hours on Day 16) Post IR ASA 81 mg Administration
Day 16 at 3 hour
|
98.80 percentage
Interval 98.49 to
One-sided 95% CI
|
97.67 percentage
Interval 97.41 to
One-sided 95% CI
|
98.02 percentage
Interval 97.68 to
One-sided 95% CI
|
99.68 percentage
Interval 99.6 to
One-sided 95% CI
|
99.19 percentage
Interval 99.0 to
One-sided 95% CI
|
98.53 percentage
Interval 98.23 to
One-sided 95% CI
|
|
Inhibition of Serum TXB2 on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours (Except at 24 Hours on Day 16) Post IR ASA 81 mg Administration
Day 16 at 6 hour
|
97.69 percentage
Interval 97.21 to
One-sided 95% CI
|
96.26 percentage
Interval 95.7 to
One-sided 95% CI
|
97.40 percentage
Interval 97.03 to
One-sided 95% CI
|
99.55 percentage
Interval 99.45 to
One-sided 95% CI
|
98.43 percentage
Interval 98.05 to
One-sided 95% CI
|
97.51 percentage
Interval 97.1 to
One-sided 95% CI
|
|
Inhibition of Serum TXB2 on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours (Except at 24 Hours on Day 16) Post IR ASA 81 mg Administration
Day 16 at 12 hour
|
96.59 percentage
Interval 95.67 to
One-sided 95% CI
|
92.71 percentage
Interval 91.13 to
One-sided 95% CI
|
96.31 percentage
Interval 95.68 to
One-sided 95% CI
|
99.42 percentage
Interval 99.29 to
One-sided 95% CI
|
97.84 percentage
Interval 97.1 to
One-sided 95% CI
|
95.38 percentage
Interval 94.13 to
One-sided 95% CI
|
|
Inhibition of Serum TXB2 on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours (Except at 24 Hours on Day 16) Post IR ASA 81 mg Administration
Day 16 at 18 hour
|
94.19 percentage
Interval 93.04 to
One-sided 95% CI
|
92.23 percentage
Interval 90.24 to
One-sided 95% CI
|
95.68 percentage
Interval 94.62 to
One-sided 95% CI
|
99.01 percentage
Interval 98.85 to
One-sided 95% CI
|
96.45 percentage
Interval 95.43 to
One-sided 95% CI
|
97.73 percentage
Interval 97.28 to
One-sided 95% CI
|
|
Inhibition of Serum TXB2 on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours (Except at 24 Hours on Day 16) Post IR ASA 81 mg Administration
Day 17 at 1 hour
|
95.71 percentage
Interval 94.31 to
One-sided 95% CI
|
94.63 percentage
Interval 93.66 to
One-sided 95% CI
|
95.56 percentage
Interval 94.69 to
One-sided 95% CI
|
99.70 percentage
Interval 99.64 to
One-sided 95% CI
|
97.42 percentage
Interval 96.88 to
One-sided 95% CI
|
96.95 percentage
Interval 96.3 to
One-sided 95% CI
|
|
Inhibition of Serum TXB2 on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours (Except at 24 Hours on Day 16) Post IR ASA 81 mg Administration
Day 17 at 3 hour
|
95.49 percentage
Interval 94.38 to
One-sided 95% CI
|
92.79 percentage
Interval 91.36 to
One-sided 95% CI
|
96.43 percentage
Interval 95.89 to
One-sided 95% CI
|
99.68 percentage
Interval 99.6 to
One-sided 95% CI
|
96.96 percentage
Interval 96.33 to
One-sided 95% CI
|
95.92 percentage
Interval 95.03 to
One-sided 95% CI
|
|
Inhibition of Serum TXB2 on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours (Except at 24 Hours on Day 16) Post IR ASA 81 mg Administration
Day 17 at 6 hour
|
93.55 percentage
Interval 91.86 to
One-sided 95% CI
|
90.91 percentage
Interval 89.21 to
One-sided 95% CI
|
95.64 percentage
Interval 94.92 to
One-sided 95% CI
|
99.52 percentage
Interval 99.41 to
One-sided 95% CI
|
95.31 percentage
Interval 94.32 to
One-sided 95% CI
|
93.91 percentage
Interval 92.61 to
One-sided 95% CI
|
|
Inhibition of Serum TXB2 on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours (Except at 24 Hours on Day 16) Post IR ASA 81 mg Administration
Day 17 at 12 hour
|
92.54 percentage
Interval 91.08 to
One-sided 95% CI
|
91.15 percentage
Interval 89.8 to
One-sided 95% CI
|
94.13 percentage
Interval 93.08 to
One-sided 95% CI
|
99.30 percentage
Interval 99.13 to
One-sided 95% CI
|
94.74 percentage
Interval 93.62 to
One-sided 95% CI
|
92.60 percentage
Interval 90.92 to
One-sided 95% CI
|
|
Inhibition of Serum TXB2 on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours (Except at 24 Hours on Day 16) Post IR ASA 81 mg Administration
Day 17 at 18 hour
|
89.44 percentage
Interval 87.48 to
One-sided 95% CI
|
87.19 percentage
Interval 85.43 to
One-sided 95% CI
|
94.23 percentage
Interval 93.42 to
One-sided 95% CI
|
98.95 percentage
Interval 98.76 to
One-sided 95% CI
|
93.42 percentage
Interval 92.27 to
One-sided 95% CI
|
88.14 percentage
Interval 85.42 to
One-sided 95% CI
|
|
Inhibition of Serum TXB2 on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours (Except at 24 Hours on Day 16) Post IR ASA 81 mg Administration
Day 17 at 24 hour
|
89.05 percentage
Interval 86.86 to
One-sided 95% CI
|
83.67 percentage
Interval 81.77 to
One-sided 95% CI
|
90.39 percentage
Interval 88.57 to
One-sided 95% CI
|
98.70 percentage
Interval 98.48 to
One-sided 95% CI
|
91.40 percentage
Interval 89.21 to
One-sided 95% CI
|
84.27 percentage
Interval 80.66 to
One-sided 95% CI
|
|
Inhibition of Serum TXB2 on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours (Except at 24 Hours on Day 16) Post IR ASA 81 mg Administration
Day 19 at 1 hour
|
98.35 percentage
Interval 97.86 to
One-sided 95% CI
|
97.89 percentage
Interval 97.45 to
One-sided 95% CI
|
98.89 percentage
Interval 98.64 to
One-sided 95% CI
|
99.69 percentage
Interval 99.62 to
One-sided 95% CI
|
98.16 percentage
Interval 97.74 to
One-sided 95% CI
|
94.06 percentage
Interval 92.59 to
One-sided 95% CI
|
|
Inhibition of Serum TXB2 on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours (Except at 24 Hours on Day 16) Post IR ASA 81 mg Administration
Day 19 at 3 hour
|
98.52 percentage
Interval 98.02 to
One-sided 95% CI
|
97.90 percentage
Interval 97.46 to
One-sided 95% CI
|
99.05 percentage
Interval 98.93 to
One-sided 95% CI
|
99.64 percentage
Interval 99.55 to
One-sided 95% CI
|
98.27 percentage
Interval 97.92 to
One-sided 95% CI
|
94.44 percentage
Interval 92.92 to
One-sided 95% CI
|
|
Inhibition of Serum TXB2 on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours (Except at 24 Hours on Day 16) Post IR ASA 81 mg Administration
Day 19 at 6 hour
|
98.26 percentage
Interval 97.78 to
One-sided 95% CI
|
97.43 percentage
Interval 96.73 to
One-sided 95% CI
|
98.98 percentage
Interval 98.81 to
One-sided 95% CI
|
99.50 percentage
Interval 99.39 to
One-sided 95% CI
|
97.84 percentage
Interval 97.34 to
One-sided 95% CI
|
93.25 percentage
Interval 91.11 to
One-sided 95% CI
|
|
Inhibition of Serum TXB2 on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours (Except at 24 Hours on Day 16) Post IR ASA 81 mg Administration
Day 19 at 12 hour
|
97.67 percentage
Interval 96.95 to
One-sided 95% CI
|
96.90 percentage
Interval 96.06 to
One-sided 95% CI
|
98.77 percentage
Interval 98.57 to
One-sided 95% CI
|
99.26 percentage
Interval 99.09 to
One-sided 95% CI
|
97.33 percentage
Interval 96.7 to
One-sided 95% CI
|
92.00 percentage
Interval 89.44 to
One-sided 95% CI
|
|
Inhibition of Serum TXB2 on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours (Except at 24 Hours on Day 16) Post IR ASA 81 mg Administration
Day 19 at 18 hour
|
97.21 percentage
Interval 96.4 to
One-sided 95% CI
|
96.29 percentage
Interval 95.4 to
One-sided 95% CI
|
98.52 percentage
Interval 98.27 to
One-sided 95% CI
|
98.88 percentage
Interval 98.67 to
One-sided 95% CI
|
96.62 percentage
Interval 95.86 to
One-sided 95% CI
|
90.94 percentage
Interval 88.41 to
One-sided 95% CI
|
SECONDARY outcome
Timeframe: At 1, 3, 6, 12, 18, and 24 hours on Days 7, 16, 17, and 19Population: Percentages are based on the number of participants in the Evaluable Population in each treatment group. Evaluable participants number in Group 4 at time point Day 7/1 Hour was 12; 11 in group 6, 7 in Group 5, 12 in Group 6 at Day 16/1 Hour.
Inhibition of AA-induced platelet aggregation at each time point were calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value - Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% CI were calculated. The platelet aggregation change-from-baseline scores range broadly in large part due to inclusion of participants with low baseline platelet aggregation scores.
Outcome measures
| Measure |
Group 1-IR ASA Co-administered With Naproxen Sodium
n=13 Participants
Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
|
Group 2-IR ASA 30 Min After Naproxen Sodium
n=14 Participants
Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
|
Group 3-IR ASA 8 Hours After Naproxen Sodium
n=15 Participants
Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
|
Group 4-IR ASA Only
n=13 Participants
Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.
|
Group 5-IR ASA 30 Min Before Naproxen Sodium
n=10 Participants
Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
|
Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid
n=14 Participants
Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
|
|---|---|---|---|---|---|---|
|
Inhibition of Arachidonic Acid (AA)-Induced Platelet Aggregation on Days 7, 16, 17, and 19 at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Day 7 at 1 hour
|
58.60 percentage
95% Confidence Interval 58.893 • Interval 29.49 to
One-sided 95% CI
|
12.78 percentage
95% Confidence Interval 139.818 • Interval -53.4 to
One-sided 95% CI
|
5.55 percentage
95% Confidence Interval 306.389 • Interval -133.79 to
One-sided 95% CI
|
87.73 percentage
95% Confidence Interval 8.777 • Interval 83.18 to
One-sided 95% CI
|
64.14 percentage
95% Confidence Interval 40.389 • Interval 40.73 to
One-sided 95% CI
|
30.45 percentage
95% Confidence Interval 182.916 • Interval -56.12 to
One-sided 95% CI
|
|
Inhibition of Arachidonic Acid (AA)-Induced Platelet Aggregation on Days 7, 16, 17, and 19 at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Day 7 at 3 hour
|
-121.76 percentage
95% Confidence Interval 630.765 • Interval -433.56 to
One-sided 95% CI
|
12.86 percentage
95% Confidence Interval 144.823 • Interval -55.68 to
One-sided 95% CI
|
10.80 percentage
95% Confidence Interval 280.405 • Interval -116.72 to
One-sided 95% CI
|
79.16 percentage
95% Confidence Interval 29.318 • Interval 64.67 to
One-sided 95% CI
|
75.89 percentage
95% Confidence Interval 24.067 • Interval 61.94 to
One-sided 95% CI
|
18.99 percentage
95% Confidence Interval 222.208 • Interval -86.18 to
One-sided 95% CI
|
|
Inhibition of Arachidonic Acid (AA)-Induced Platelet Aggregation on Days 7, 16, 17, and 19 at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Day 7 at 6 hour
|
61.74 percentage
95% Confidence Interval 63.400 • Interval 30.4 to
One-sided 95% CI
|
1.70 percentage
95% Confidence Interval 168.415 • Interval -78.01 to
One-sided 95% CI
|
-3.29 percentage
95% Confidence Interval 331.881 • Interval -154.22 to
One-sided 95% CI
|
78.20 percentage
95% Confidence Interval 33.051 • Interval 61.86 to
One-sided 95% CI
|
73.69 percentage
95% Confidence Interval 31.859 • Interval 55.22 to
One-sided 95% CI
|
26.91 percentage
95% Confidence Interval 183.636 • Interval -60.0 to
One-sided 95% CI
|
|
Inhibition of Arachidonic Acid (AA)-Induced Platelet Aggregation on Days 7, 16, 17, and 19 at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Day 7 at 12 hour
|
36.41 percentage
95% Confidence Interval 162.350 • Interval -43.85 to
One-sided 95% CI
|
28.54 percentage
95% Confidence Interval 113.063 • Interval -24.98 to
One-sided 95% CI
|
-17.95 percentage
95% Confidence Interval 275.811 • Interval -143.38 to
One-sided 95% CI
|
80.81 percentage
95% Confidence Interval 33.244 • Interval 64.37 to
One-sided 95% CI
|
76.02 percentage
95% Confidence Interval 26.733 • Interval 60.52 to
One-sided 95% CI
|
17.11 percentage
95% Confidence Interval 249.918 • Interval -101.18 to
One-sided 95% CI
|
|
Inhibition of Arachidonic Acid (AA)-Induced Platelet Aggregation on Days 7, 16, 17, and 19 at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Day 7 at 18 hour
|
62.36 percentage
95% Confidence Interval 68.382 • Interval 28.56 to
One-sided 95% CI
|
25.27 percentage
95% Confidence Interval 119.755 • Interval -31.41 to
One-sided 95% CI
|
11.96 percentage
95% Confidence Interval 280.718 • Interval -115.7 to
One-sided 95% CI
|
78.50 percentage
95% Confidence Interval 37.671 • Interval 59.88 to
One-sided 95% CI
|
38.58 percentage
95% Confidence Interval 138.715 • Interval -41.83 to
One-sided 95% CI
|
-151.06 percentage
95% Confidence Interval 863.434 • Interval -559.72 to
One-sided 95% CI
|
|
Inhibition of Arachidonic Acid (AA)-Induced Platelet Aggregation on Days 7, 16, 17, and 19 at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Day 7 at 24 hour
|
80.60 percentage
95% Confidence Interval 26.517 • Interval 67.5 to
One-sided 95% CI
|
46.31 percentage
95% Confidence Interval 91.924 • Interval 2.8 to
One-sided 95% CI
|
41.29 percentage
95% Confidence Interval 178.089 • Interval -39.7 to
One-sided 95% CI
|
89.12 percentage
95% Confidence Interval 18.535 • Interval 79.96 to
One-sided 95% CI
|
77.61 percentage
95% Confidence Interval 29.401 • Interval 60.57 to
One-sided 95% CI
|
44.02 percentage
95% Confidence Interval 157.466 • Interval -30.51 to
One-sided 95% CI
|
|
Inhibition of Arachidonic Acid (AA)-Induced Platelet Aggregation on Days 7, 16, 17, and 19 at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Day 16 at 1 hour
|
68.96 percentage
95% Confidence Interval 39.662 • Interval 49.36 to
One-sided 95% CI
|
24.15 percentage
95% Confidence Interval 114.782 • Interval -38.58 to
One-sided 95% CI
|
29.25 percentage
95% Confidence Interval 229.744 • Interval -75.23 to
One-sided 95% CI
|
86.12 percentage
95% Confidence Interval 21.728 • Interval 75.38 to
One-sided 95% CI
|
62.67 percentage
95% Confidence Interval 45.474 • Interval 29.27 to
One-sided 95% CI
|
45.12 percentage
95% Confidence Interval 141.196 • Interval -28.08 to
One-sided 95% CI
|
|
Inhibition of Arachidonic Acid (AA)-Induced Platelet Aggregation on Days 7, 16, 17, and 19 at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Day 16 at 3 hour
|
75.25 percentage
95% Confidence Interval 42.568 • Interval 54.21 to
One-sided 95% CI
|
51.22 percentage
95% Confidence Interval 74.825 • Interval 15.81 to
One-sided 95% CI
|
33.12 percentage
95% Confidence Interval 203.704 • Interval -59.52 to
One-sided 95% CI
|
85.92 percentage
95% Confidence Interval 21.762 • Interval 75.16 to
One-sided 95% CI
|
83.51 percentage
95% Confidence Interval 21.986 • Interval 70.77 to
One-sided 95% CI
|
37.09 percentage
95% Confidence Interval 170.694 • Interval -43.7 to
One-sided 95% CI
|
|
Inhibition of Arachidonic Acid (AA)-Induced Platelet Aggregation on Days 7, 16, 17, and 19 at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Day 16 at 6 hour
|
74.45 percentage
95% Confidence Interval 42.678 • Interval 53.35 to
One-sided 95% CI
|
61.20 percentage
95% Confidence Interval 63.333 • Interval 31.22 to
One-sided 95% CI
|
62.32 percentage
95% Confidence Interval 100.840 • Interval 16.46 to
One-sided 95% CI
|
81.36 percentage
95% Confidence Interval 37.422 • Interval 62.86 to
One-sided 95% CI
|
82.55 percentage
95% Confidence Interval 17.893 • Interval 72.18 to
One-sided 95% CI
|
81.07 percentage
95% Confidence Interval 26.570 • Interval 68.49 to
One-sided 95% CI
|
|
Inhibition of Arachidonic Acid (AA)-Induced Platelet Aggregation on Days 7, 16, 17, and 19 at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Day 16 at 12 hour
|
79.88 percentage
95% Confidence Interval 26.425 • Interval 66.81 to
One-sided 95% CI
|
70.98 percentage
95% Confidence Interval 51.499 • Interval 46.61 to
One-sided 95% CI
|
11.16 percentage
95% Confidence Interval 254.042 • Interval -104.37 to
One-sided 95% CI
|
81.38 percentage
95% Confidence Interval 31.472 • Interval 65.82 to
One-sided 95% CI
|
79.51 percentage
95% Confidence Interval 21.218 • Interval 67.21 to
One-sided 95% CI
|
53.04 percentage
95% Confidence Interval 118.315 • Interval -2.96 to
One-sided 95% CI
|
|
Inhibition of Arachidonic Acid (AA)-Induced Platelet Aggregation on Days 7, 16, 17, and 19 at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Day 16 at 18 hour
|
73.86 percentage
95% Confidence Interval 36.769 • Interval 55.68 to
One-sided 95% CI
|
74.07 percentage
95% Confidence Interval 40.473 • Interval 54.92 to
One-sided 95% CI
|
35.43 percentage
95% Confidence Interval 204.054 • Interval -57.37 to
One-sided 95% CI
|
85.19 percentage
95% Confidence Interval 25.762 • Interval 72.45 to
One-sided 95% CI
|
71.93 percentage
95% Confidence Interval 52.602 • Interval 41.44 to
One-sided 95% CI
|
71.64 percentage
95% Confidence Interval 52.123 • Interval 46.97 to
One-sided 95% CI
|
|
Inhibition of Arachidonic Acid (AA)-Induced Platelet Aggregation on Days 7, 16, 17, and 19 at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Day 16 at 24 hour
|
67.47 percentage
95% Confidence Interval 37.467 • Interval 48.95 to
One-sided 95% CI
|
64.26 percentage
95% Confidence Interval 51.050 • Interval 40.1 to
One-sided 95% CI
|
15.96 percentage
95% Confidence Interval 281.846 • Interval -112.22 to
One-sided 95% CI
|
85.25 percentage
95% Confidence Interval 18.848 • Interval 75.93 to
One-sided 95% CI
|
73.73 percentage
95% Confidence Interval 32.648 • Interval 54.81 to
One-sided 95% CI
|
51.40 percentage
95% Confidence Interval 116.489 • Interval -3.73 to
One-sided 95% CI
|
|
Inhibition of Arachidonic Acid (AA)-Induced Platelet Aggregation on Days 7, 16, 17, and 19 at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Day 17 at 1 hour
|
76.23 percentage
95% Confidence Interval 30.966 • Interval 60.92 to
One-sided 95% CI
|
56.77 percentage
95% Confidence Interval 63.792 • Interval 26.57 to
One-sided 95% CI
|
-452.48 percentage
95% Confidence Interval 2088.027 • Interval -1402.05 to
One-sided 95% CI
|
83.53 percentage
95% Confidence Interval 25.476 • Interval 70.94 to
One-sided 95% CI
|
82.13 percentage
95% Confidence Interval 19.364 • Interval 70.9 to
One-sided 95% CI
|
33.64 percentage
95% Confidence Interval 197.114 • Interval -59.65 to
One-sided 95% CI
|
|
Inhibition of Arachidonic Acid (AA)-Induced Platelet Aggregation on Days 7, 16, 17, and 19 at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Day 17 at 3 hour
|
78.48 percentage
95% Confidence Interval 27.969 • Interval 64.66 to
One-sided 95% CI
|
46.16 percentage
95% Confidence Interval 79.122 • Interval 8.71 to
One-sided 95% CI
|
21.74 percentage
95% Confidence Interval 255.742 • Interval -94.56 to
One-sided 95% CI
|
83.48 percentage
95% Confidence Interval 25.466 • Interval 70.89 to
One-sided 95% CI
|
75.15 percentage
95% Confidence Interval 30.948 • Interval 57.21 to
One-sided 95% CI
|
48.27 percentage
95% Confidence Interval 117.511 • Interval -7.35 to
One-sided 95% CI
|
|
Inhibition of Arachidonic Acid (AA)-Induced Platelet Aggregation on Days 7, 16, 17, and 19 at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Day 17 at 6 hour
|
76.46 percentage
95% Confidence Interval 36.017 • Interval 58.65 to
One-sided 95% CI
|
69.16 percentage
95% Confidence Interval 43.503 • Interval 48.57 to
One-sided 95% CI
|
37.52 percentage
95% Confidence Interval 204.341 • Interval -55.41 to
One-sided 95% CI
|
83.48 percentage
95% Confidence Interval 25.514 • Interval 70.87 to
One-sided 95% CI
|
74.61 percentage
95% Confidence Interval 38.546 • Interval 52.27 to
One-sided 95% CI
|
52.03 percentage
95% Confidence Interval 131.415 • Interval -10.17 to
One-sided 95% CI
|
|
Inhibition of Arachidonic Acid (AA)-Induced Platelet Aggregation on Days 7, 16, 17, and 19 at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Day 17 at 12 hour
|
83.17 percentage
95% Confidence Interval 20.398 • Interval 73.08 to
One-sided 95% CI
|
86.40 percentage
95% Confidence Interval 17.991 • Interval 77.88 to
One-sided 95% CI
|
-24.72 percentage
95% Confidence Interval 408.994 • Interval -210.72 to
One-sided 95% CI
|
86.00 percentage
95% Confidence Interval 17.935 • Interval 77.13 to
One-sided 95% CI
|
82.37 percentage
95% Confidence Interval 27.172 • Interval 66.62 to
One-sided 95% CI
|
67.55 percentage
95% Confidence Interval 79.461 • Interval 29.95 to
One-sided 95% CI
|
|
Inhibition of Arachidonic Acid (AA)-Induced Platelet Aggregation on Days 7, 16, 17, and 19 at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Day 17 at 18 hour
|
82.30 percentage
95% Confidence Interval 22.570 • Interval 71.15 to
One-sided 95% CI
|
68.65 percentage
95% Confidence Interval 45.824 • Interval 46.96 to
One-sided 95% CI
|
31.96 percentage
95% Confidence Interval 178.297 • Interval -49.12 to
One-sided 95% CI
|
83.71 percentage
95% Confidence Interval 25.383 • Interval 71.17 to
One-sided 95% CI
|
71.35 percentage
95% Confidence Interval 31.709 • Interval 52.97 to
One-sided 95% CI
|
41.51 percentage
95% Confidence Interval 144.334 • Interval -26.81 to
One-sided 95% CI
|
|
Inhibition of Arachidonic Acid (AA)-Induced Platelet Aggregation on Days 7, 16, 17, and 19 at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Day 17 at 24 hour
|
78.66 percentage
95% Confidence Interval 36.988 • Interval 60.37 to
One-sided 95% CI
|
70.84 percentage
95% Confidence Interval 46.622 • Interval 48.77 to
One-sided 95% CI
|
53.24 percentage
95% Confidence Interval 103.247 • Interval 6.29 to
One-sided 95% CI
|
85.43 percentage
95% Confidence Interval 25.873 • Interval 72.64 to
One-sided 95% CI
|
82.13 percentage
95% Confidence Interval 29.286 • Interval 65.15 to
One-sided 95% CI
|
87.02 percentage
95% Confidence Interval 23.703 • Interval 75.8 to
One-sided 95% CI
|
|
Inhibition of Arachidonic Acid (AA)-Induced Platelet Aggregation on Days 7, 16, 17, and 19 at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Day 19 at 1 hour
|
64.06 percentage
95% Confidence Interval 64.304 • Interval 32.28 to
One-sided 95% CI
|
41.10 percentage
95% Confidence Interval 103.816 • Interval -8.04 to
One-sided 95% CI
|
21.46 percentage
95% Confidence Interval 255.470 • Interval -94.72 to
One-sided 95% CI
|
83.97 percentage
95% Confidence Interval 25.386 • Interval 71.42 to
One-sided 95% CI
|
81.05 percentage
95% Confidence Interval 19.743 • Interval 69.6 to
One-sided 95% CI
|
43.92 percentage
95% Confidence Interval 157.676 • Interval -30.71 to
One-sided 95% CI
|
|
Inhibition of Arachidonic Acid (AA)-Induced Platelet Aggregation on Days 7, 16, 17, and 19 at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Day 19 at 3 hour
|
69.18 percentage
95% Confidence Interval 58.761 • Interval 40.13 to
One-sided 95% CI
|
48.51 percentage
95% Confidence Interval 73.341 • Interval 13.8 to
One-sided 95% CI
|
23.64 percentage
95% Confidence Interval 228.479 • Interval -80.27 to
One-sided 95% CI
|
81.62 percentage
95% Confidence Interval 33.415 • Interval 65.1 to
One-sided 95% CI
|
78.01 percentage
95% Confidence Interval 26.265 • Interval 62.78 to
One-sided 95% CI
|
14.85 percentage
95% Confidence Interval 263.930 • Interval -110.07 to
One-sided 95% CI
|
|
Inhibition of Arachidonic Acid (AA)-Induced Platelet Aggregation on Days 7, 16, 17, and 19 at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Day 19 at 6 hour
|
60.96 percentage
95% Confidence Interval 72.629 • Interval 25.06 to
One-sided 95% CI
|
50.21 percentage
95% Confidence Interval 77.242 • Interval 13.65 to
One-sided 95% CI
|
51.59 percentage
95% Confidence Interval 126.753 • Interval -6.05 to
One-sided 95% CI
|
82.98 percentage
95% Confidence Interval 29.512 • Interval 68.39 to
One-sided 95% CI
|
70.87 percentage
95% Confidence Interval 35.515 • Interval 50.28 to
One-sided 95% CI
|
58.64 percentage
95% Confidence Interval 105.239 • Interval 8.83 to
One-sided 95% CI
|
|
Inhibition of Arachidonic Acid (AA)-Induced Platelet Aggregation on Days 7, 16, 17, and 19 at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Day 19 at 12 hour
|
1.08 percentage
95% Confidence Interval 313.927 • Interval -154.1 to
One-sided 95% CI
|
33.43 percentage
95% Confidence Interval 110.105 • Interval -18.68 to
One-sided 95% CI
|
36.92 percentage
95% Confidence Interval 204.360 • Interval -56.02 to
One-sided 95% CI
|
84.45 percentage
95% Confidence Interval 25.743 • Interval 71.72 to
One-sided 95% CI
|
44.97 percentage
95% Confidence Interval 112.099 • Interval -20.01 to
One-sided 95% CI
|
13.17 percentage
95% Confidence Interval 215.066 • Interval -88.62 to
One-sided 95% CI
|
|
Inhibition of Arachidonic Acid (AA)-Induced Platelet Aggregation on Days 7, 16, 17, and 19 at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Day 19 at 18 hour
|
69.69 percentage
95% Confidence Interval 57.918 • Interval 41.06 to
One-sided 95% CI
|
74.55 percentage
95% Confidence Interval 46.130 • Interval 52.71 to
One-sided 95% CI
|
15.41 percentage
95% Confidence Interval 281.253 • Interval -112.49 to
One-sided 95% CI
|
91.12 percentage
95% Confidence Interval 4.541 • Interval 88.88 to
One-sided 95% CI
|
88.43 percentage
95% Confidence Interval 10.953 • Interval 82.08 to
One-sided 95% CI
|
84.46 percentage
95% Confidence Interval 28.685 • Interval 70.88 to
One-sided 95% CI
|
|
Inhibition of Arachidonic Acid (AA)-Induced Platelet Aggregation on Days 7, 16, 17, and 19 at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Day 19 at 24 hour
|
89.86 percentage
95% Confidence Interval 13.568 • Interval 83.15 to
One-sided 95% CI
|
80.90 percentage
95% Confidence Interval 28.329 • Interval 67.49 to
One-sided 95% CI
|
29.02 percentage
95% Confidence Interval 230.055 • Interval -75.6 to
One-sided 95% CI
|
83.67 percentage
95% Confidence Interval 34.194 • Interval 66.77 to
One-sided 95% CI
|
82.63 percentage
95% Confidence Interval 20.393 • Interval 70.8 to
One-sided 95% CI
|
71.27 percentage
95% Confidence Interval 57.042 • Interval 44.27 to
One-sided 95% CI
|
SECONDARY outcome
Timeframe: At 1, 3, 6, 12, 18, and 24 hours on Days 7, 16, 17, and 19Population: Percentages are based on the number of participants in the Evaluable Population in each treatment group. Evaluable participants number in Group 1 at time point Day 7/1 Hour, Day 7/3 Hour, Day 7/6 Hour, Day 7/12 Hour was 12.
Inhibition of plasma TXB2 at each time point were calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value - Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% CI were calculated.
Outcome measures
| Measure |
Group 1-IR ASA Co-administered With Naproxen Sodium
n=13 Participants
Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
|
Group 2-IR ASA 30 Min After Naproxen Sodium
n=14 Participants
Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
|
Group 3-IR ASA 8 Hours After Naproxen Sodium
n=15 Participants
Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
|
Group 4-IR ASA Only
n=13 Participants
Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.
|
Group 5-IR ASA 30 Min Before Naproxen Sodium
n=10 Participants
Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
|
Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid
n=15 Participants
Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
|
|---|---|---|---|---|---|---|
|
Inhibition of TXB2 Using Platelet-rich Plasma (PRP) on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Day 16 at 1 hour
|
98.06 percentage
Interval 97.15 to
One-sided 95% CI
|
95.49 percentage
Interval 93.79 to
One-sided 95% CI
|
89.55 percentage
Interval 87.09 to
One-sided 95% CI
|
98.99 percentage
Interval 98.59 to
One-sided 95% CI
|
96.73 percentage
Interval 95.54 to
One-sided 95% CI
|
94.95 percentage
Interval 92.99 to
One-sided 95% CI
|
|
Inhibition of TXB2 Using Platelet-rich Plasma (PRP) on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Day 16 at 3 hour
|
93.03 percentage
Interval 90.35 to
One-sided 95% CI
|
89.25 percentage
Interval 85.98 to
One-sided 95% CI
|
92.62 percentage
Interval 90.24 to
One-sided 95% CI
|
97.37 percentage
Interval 96.45 to
One-sided 95% CI
|
96.17 percentage
Interval 95.16 to
One-sided 95% CI
|
90.62 percentage
Interval 87.59 to
One-sided 95% CI
|
|
Inhibition of TXB2 Using Platelet-rich Plasma (PRP) on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Day 16 at 6 hour
|
93.55 percentage
Interval 89.83 to
One-sided 95% CI
|
88.62 percentage
Interval 83.96 to
One-sided 95% CI
|
90.40 percentage
Interval 88.3 to
One-sided 95% CI
|
98.50 percentage
Interval 97.89 to
One-sided 95% CI
|
95.56 percentage
Interval 93.74 to
One-sided 95% CI
|
91.27 percentage
Interval 87.89 to
One-sided 95% CI
|
|
Inhibition of TXB2 Using Platelet-rich Plasma (PRP) on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Day 16 at 12 hour
|
89.55 percentage
Interval 86.8 to
One-sided 95% CI
|
85.63 percentage
Interval 80.5 to
One-sided 95% CI
|
88.76 percentage
Interval 85.89 to
One-sided 95% CI
|
97.42 percentage
Interval 96.77 to
One-sided 95% CI
|
92.30 percentage
Interval 90.55 to
One-sided 95% CI
|
89.45 percentage
Interval 84.52 to
One-sided 95% CI
|
|
Inhibition of TXB2 Using Platelet-rich Plasma (PRP) on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Day 16 at 18 hour
|
86.61 percentage
Interval 82.69 to
One-sided 95% CI
|
84.41 percentage
Interval 80.03 to
One-sided 95% CI
|
82.14 percentage
Interval 75.75 to
One-sided 95% CI
|
95.69 percentage
Interval 94.57 to
One-sided 95% CI
|
93.28 percentage
Interval 91.0 to
One-sided 95% CI
|
91.03 percentage
Interval 87.81 to
One-sided 95% CI
|
|
Inhibition of TXB2 Using Platelet-rich Plasma (PRP) on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Day 16 at 24 hour
|
86.42 percentage
Interval 80.81 to
One-sided 95% CI
|
72.66 percentage
Interval 65.53 to
One-sided 95% CI
|
77.71 percentage
Interval 72.15 to
One-sided 95% CI
|
95.78 percentage
Interval 94.35 to
One-sided 95% CI
|
88.49 percentage
Interval 84.08 to
One-sided 95% CI
|
86.87 percentage
Interval 81.86 to
One-sided 95% CI
|
|
Inhibition of TXB2 Using Platelet-rich Plasma (PRP) on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Day 17 at 1 hour
|
86.19 percentage
Interval 80.48 to
One-sided 95% CI
|
79.99 percentage
Interval 74.59 to
One-sided 95% CI
|
86.14 percentage
Interval 83.15 to
One-sided 95% CI
|
98.72 percentage
Interval 98.3 to
One-sided 95% CI
|
93.75 percentage
Interval 91.26 to
One-sided 95% CI
|
90.00 percentage
Interval 84.47 to
One-sided 95% CI
|
|
Inhibition of TXB2 Using Platelet-rich Plasma (PRP) on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Day 17 at 3 hour
|
85.45 percentage
Interval 79.85 to
One-sided 95% CI
|
90.16 percentage
Interval 87.39 to
One-sided 95% CI
|
92.60 percentage
Interval 90.38 to
One-sided 95% CI
|
98.01 percentage
Interval 97.13 to
One-sided 95% CI
|
88.52 percentage
Interval 84.47 to
One-sided 95% CI
|
83.94 percentage
Interval 78.25 to
One-sided 95% CI
|
|
Inhibition of TXB2 Using Platelet-rich Plasma (PRP) on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Day 17 at 6 hour
|
82.90 percentage
Interval 75.87 to
One-sided 95% CI
|
84.77 percentage
Interval 80.99 to
One-sided 95% CI
|
83.08 percentage
Interval 77.53 to
One-sided 95% CI
|
97.34 percentage
Interval 96.57 to
One-sided 95% CI
|
92.39 percentage
Interval 89.45 to
One-sided 95% CI
|
85.82 percentage
Interval 79.55 to
One-sided 95% CI
|
|
Inhibition of TXB2 Using Platelet-rich Plasma (PRP) on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Day 17 at 12 hour
|
83.49 percentage
Interval 76.38 to
One-sided 95% CI
|
81.22 percentage
Interval 75.88 to
One-sided 95% CI
|
86.50 percentage
Interval 82.09 to
One-sided 95% CI
|
97.46 percentage
Interval 96.4 to
One-sided 95% CI
|
92.42 percentage
Interval 88.9 to
One-sided 95% CI
|
82.13 percentage
Interval 76.07 to
One-sided 95% CI
|
|
Inhibition of TXB2 Using Platelet-rich Plasma (PRP) on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Day 17 at 18 hour
|
85.77 percentage
Interval 81.67 to
One-sided 95% CI
|
78.34 percentage
Interval 72.79 to
One-sided 95% CI
|
86.53 percentage
Interval 82.83 to
One-sided 95% CI
|
95.47 percentage
Interval 93.79 to
One-sided 95% CI
|
85.70 percentage
Interval 82.5 to
One-sided 95% CI
|
70.90 percentage
Interval 62.89 to
One-sided 95% CI
|
|
Inhibition of TXB2 Using Platelet-rich Plasma (PRP) on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Day 17 at 24 hour
|
79.55 percentage
Interval 72.74 to
One-sided 95% CI
|
79.06 percentage
Interval 72.89 to
One-sided 95% CI
|
75.67 percentage
Interval 70.44 to
One-sided 95% CI
|
97.23 percentage
Interval 96.19 to
One-sided 95% CI
|
92.07 percentage
Interval 89.87 to
One-sided 95% CI
|
81.34 percentage
Interval 76.55 to
One-sided 95% CI
|
|
Inhibition of TXB2 Using Platelet-rich Plasma (PRP) on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Day 19 at 1 hour
|
92.68 percentage
Interval 89.5 to
One-sided 95% CI
|
89.65 percentage
Interval 86.17 to
One-sided 95% CI
|
95.32 percentage
Interval 93.74 to
One-sided 95% CI
|
98.05 percentage
Interval 97.37 to
One-sided 95% CI
|
94.39 percentage
Interval 91.69 to
One-sided 95% CI
|
79.36 percentage
Interval 73.75 to
One-sided 95% CI
|
|
Inhibition of TXB2 Using Platelet-rich Plasma (PRP) on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Day 19 at 3 hour
|
91.03 percentage
Interval 88.18 to
One-sided 95% CI
|
92.04 percentage
Interval 90.13 to
One-sided 95% CI
|
93.68 percentage
Interval 91.71 to
One-sided 95% CI
|
97.82 percentage
Interval 97.16 to
One-sided 95% CI
|
94.53 percentage
Interval 91.78 to
One-sided 95% CI
|
79.82 percentage
Interval 74.39 to
One-sided 95% CI
|
|
Inhibition of TXB2 Using Platelet-rich Plasma (PRP) on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Day 19 at 6 hour
|
90.57 percentage
Interval 87.64 to
One-sided 95% CI
|
91.49 percentage
Interval 88.95 to
One-sided 95% CI
|
92.35 percentage
Interval 90.34 to
One-sided 95% CI
|
98.24 percentage
Interval 97.66 to
One-sided 95% CI
|
93.72 percentage
Interval 90.55 to
One-sided 95% CI
|
81.14 percentage
Interval 77.02 to
One-sided 95% CI
|
|
Inhibition of TXB2 Using Platelet-rich Plasma (PRP) on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Day 19 at 12 hour
|
91.59 percentage
Interval 88.31 to
One-sided 95% CI
|
89.25 percentage
Interval 86.51 to
One-sided 95% CI
|
95.18 percentage
Interval 93.46 to
One-sided 95% CI
|
96.91 percentage
Interval 95.87 to
One-sided 95% CI
|
92.84 percentage
Interval 90.52 to
One-sided 95% CI
|
80.66 percentage
Interval 75.32 to
One-sided 95% CI
|
|
Inhibition of TXB2 Using Platelet-rich Plasma (PRP) on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Day 19 at 18 hour
|
91.20 percentage
Interval 87.58 to
One-sided 95% CI
|
93.50 percentage
Interval 91.0 to
One-sided 95% CI
|
94.85 percentage
Interval 92.96 to
One-sided 95% CI
|
96.24 percentage
Interval 95.27 to
One-sided 95% CI
|
92.74 percentage
Interval 89.92 to
One-sided 95% CI
|
85.67 percentage
Interval 81.17 to
One-sided 95% CI
|
|
Inhibition of TXB2 Using Platelet-rich Plasma (PRP) on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Day 19 at 24 hour
|
93.76 percentage
Interval 91.18 to
One-sided 95% CI
|
90.93 percentage
Interval 87.8 to
One-sided 95% CI
|
93.66 percentage
Interval 91.58 to
One-sided 95% CI
|
96.63 percentage
Interval 95.39 to
One-sided 95% CI
|
96.14 percentage
Interval 93.74 to
One-sided 95% CI
|
81.67 percentage
Interval 74.94 to
One-sided 95% CI
|
|
Inhibition of TXB2 Using Platelet-rich Plasma (PRP) on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Day 7 at 1 hour
|
98.84 percentage
Interval 98.35 to
One-sided 95% CI
|
98.82 percentage
Interval 98.33 to
One-sided 95% CI
|
97.59 percentage
Interval 96.62 to
One-sided 95% CI
|
98.34 percentage
Interval 97.61 to
One-sided 95% CI
|
99.40 percentage
Interval 99.17 to
One-sided 95% CI
|
98.67 percentage
Interval 98.14 to
One-sided 95% CI
|
|
Inhibition of TXB2 Using Platelet-rich Plasma (PRP) on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Day 7 at 3 hour
|
97.82 percentage
Interval 97.0 to
One-sided 95% CI
|
98.25 percentage
Interval 97.48 to
One-sided 95% CI
|
97.72 percentage
Interval 97.03 to
One-sided 95% CI
|
97.61 percentage
Interval 96.55 to
One-sided 95% CI
|
98.95 percentage
Interval 98.49 to
One-sided 95% CI
|
97.68 percentage
Interval 96.44 to
One-sided 95% CI
|
|
Inhibition of TXB2 Using Platelet-rich Plasma (PRP) on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Day 7 at 6 hour
|
97.95 percentage
Interval 96.59 to
One-sided 95% CI
|
98.57 percentage
Interval 97.83 to
One-sided 95% CI
|
98.37 percentage
Interval 97.63 to
One-sided 95% CI
|
97.29 percentage
Interval 96.46 to
One-sided 95% CI
|
99.06 percentage
Interval 98.42 to
One-sided 95% CI
|
97.93 percentage
Interval 97.29 to
One-sided 95% CI
|
|
Inhibition of TXB2 Using Platelet-rich Plasma (PRP) on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Day 7 at 12 hour
|
97.75 percentage
Interval 96.69 to
One-sided 95% CI
|
97.92 percentage
Interval 96.72 to
One-sided 95% CI
|
96.66 percentage
Interval 95.59 to
One-sided 95% CI
|
97.49 percentage
Interval 96.71 to
One-sided 95% CI
|
98.54 percentage
Interval 97.7 to
One-sided 95% CI
|
98.36 percentage
Interval 97.52 to
One-sided 95% CI
|
|
Inhibition of TXB2 Using Platelet-rich Plasma (PRP) on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Day 7 at 18 hour
|
97.85 percentage
Interval 96.65 to
One-sided 95% CI
|
96.09 percentage
Interval 94.63 to
One-sided 95% CI
|
98.79 percentage
Interval 98.32 to
One-sided 95% CI
|
96.29 percentage
Interval 94.83 to
One-sided 95% CI
|
97.97 percentage
Interval 96.94 to
One-sided 95% CI
|
97.87 percentage
Interval 96.98 to
One-sided 95% CI
|
|
Inhibition of TXB2 Using Platelet-rich Plasma (PRP) on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Day 7 at 24 hour
|
96.62 percentage
Interval 95.38 to
One-sided 95% CI
|
98.26 percentage
Interval 97.59 to
One-sided 95% CI
|
98.89 percentage
Interval 98.42 to
One-sided 95% CI
|
95.04 percentage
Interval 93.35 to
One-sided 95% CI
|
98.13 percentage
Interval 97.54 to
One-sided 95% CI
|
98.44 percentage
Interval 97.81 to
One-sided 95% CI
|
Adverse Events
Group 0-IR ASA 81 mg qd in Run-in Period
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 1-IR ASA Co-administered With Naproxen Sodium
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Group 2-IR ASA 30 Min After Naproxen Sodium
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group 3-IR ASA 8 Hours After Naproxen Sodium
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Group 4-IR ASA Only
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 5-IR ASA 30 Min Before Naproxen Sodium
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 0-IR ASA 81 mg qd in Run-in Period
n=102 participants at risk
Participants, subsequently randomized to treatment period, were administered the first dose of immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily at the clinical study site and instructed to take the remaining 5 doses in a fasted state with a full glass of water once daily in the morning in an outpatient setting.
|
Group 1-IR ASA Co-administered With Naproxen Sodium
n=17 participants at risk
Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
|
Group 2-IR ASA 30 Min After Naproxen Sodium
n=17 participants at risk
Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
|
Group 3-IR ASA 8 Hours After Naproxen Sodium
n=17 participants at risk
Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
|
Group 4-IR ASA Only
n=17 participants at risk
Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.
|
Group 5-IR ASA 30 Min Before Naproxen Sodium
n=17 participants at risk
Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
|
Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid
n=17 participants at risk
Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
|
|---|---|---|---|---|---|---|---|
|
General disorders
Chest discomfort
|
0.00%
0/102 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
5.9%
1/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/102 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
5.9%
1/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/102 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
5.9%
1/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/102 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
5.9%
1/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
|
Gastrointestinal disorders
Infrequent bowel movements
|
0.00%
0/102 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
5.9%
1/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
5.9%
1/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
11.8%
2/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/102 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
5.9%
1/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/102 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
5.9%
1/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
|
General disorders
Fatigue
|
0.00%
0/102 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
5.9%
1/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/102 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
5.9%
1/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/102 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
5.9%
1/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
|
Investigations
Coagulation time prolonged
|
0.00%
0/102 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
5.9%
1/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/102 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
5.9%
1/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/102 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
5.9%
1/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
5.9%
1/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
5.9%
1/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
|
Nervous system disorders
Syncope
|
0.00%
0/102 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
5.9%
1/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/102 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
5.9%
1/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
|
Reproductive system and breast disorders
Pelvic discomfort
|
0.00%
0/102 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
5.9%
1/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/102 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
5.9%
1/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/102 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
5.9%
1/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
0.00%
0/17 • Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER