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Trial record 16 of 85 for:    ASPIRIN AND thromboxane

Naproxen Sodium/ASA Platelet Study (Kontakt)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02229461
Recruitment Status : Completed
First Posted : September 1, 2014
Results First Posted : June 10, 2016
Last Update Posted : July 15, 2016
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hematology
Interventions Drug: Naproxen Sodium (Aleve, BAY117031)
Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)
Enrollment 117
Recruitment Details 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).
Pre-assignment Details 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).
Arm/Group Title Group 1-IR ASA Co-administered With Naproxen Sodium Group 2-IR ASA 30 Min After Naproxen Sodium Group 3-IR ASA 8 Hours After Naproxen Sodium Group 4-IR ASA Only Group 5-IR ASA 30 Min Before Naproxen Sodium Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid
Hide Arm/Group Description 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. 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. 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. 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. 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. 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.
Period Title: Overall Study
Started 17 [1] 17 [1] 17 [1] 17 [1] 17 [1] 17 [1]
Completed 17 17 17 17 17 17
Not Completed 0 0 0 0 0 0
[1]
Randomized and received treatment
Arm/Group Title Group 1-IR ASA Co-administered With Naproxen Sodium Group 2-IR ASA 30 Min After Naproxen Sodium Group 3-IR ASA 8 Hours After Naproxen Sodium Group 4-IR ASA Only Group 5-IR ASA 30 Min Before Naproxen Sodium Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid Non-Randomized Total
Hide Arm/Group Description 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. 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. 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. 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. 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. 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. Fifteen participants were not randomized into Treatment Period. Total of all reporting groups
Overall Number of Baseline Participants 17 17 17 17 17 17 15 117
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 17 participants 17 participants 17 participants 17 participants 17 participants 15 participants 117 participants
41.3  (8.46) 31.2  (7.19) 37.5  (13.41) 34.2  (8.76) 38.8  (12.09) 38.9  (10.62) 38.2  (13.74) 37.1  (11.00)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 17 participants 17 participants 17 participants 17 participants 17 participants 15 participants 117 participants
Female
7
  41.2%
4
  23.5%
6
  35.3%
4
  23.5%
4
  23.5%
7
  41.2%
4
  26.7%
36
  30.8%
Male
10
  58.8%
13
  76.5%
11
  64.7%
13
  76.5%
13
  76.5%
10
  58.8%
11
  73.3%
81
  69.2%
1.Primary Outcome
Title Inhibition of Serum Thromboxane B2 (TXB2) on Day 16 at 24 Hour Post IR ASA 81 mg Administration
Hide Description 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.
Time Frame At hour 24 on Day 16 post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Percentages are based on the number of participants in the Evaluable Population in each treatment group.
Arm/Group Title Group 1-IR ASA Co-administered With Naproxen Sodium Group 2-IR ASA 30 Min After Naproxen Sodium Group 3-IR ASA 8 Hours After Naproxen Sodium Group 4-IR ASA Only Group 5-IR ASA 30 Min Before Naproxen Sodium Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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 Number of Participants Analyzed 13 14 15 13 10 15
Mean (95% Confidence Interval)
Unit of Measure: percentage
93.09 [1] 
(91.50 to NA)
87.71 [1] 
(85.51 to NA)
92.87 [1] 
(91.24 to NA)
98.72 [1] 
(98.49 to NA)
95.35 [1] 
(94.14 to NA)
95.65 [1] 
(94.74 to NA)
[1]
One-sided 95% CI
2.Secondary Outcome
Title 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
Hide Description 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.
Time Frame At 1, 3, 6, 12, 18, and 24 hours on Days 7, 16, 17, and 19 (except 24 hours on Day 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Percentages are based on the number of participants in the Evaluable Population in each treatment group.
Arm/Group Title Group 1-IR ASA Co-administered With Naproxen Sodium Group 2-IR ASA 30 Min After Naproxen Sodium Group 3-IR ASA 8 Hours After Naproxen Sodium Group 4-IR ASA Only Group 5-IR ASA 30 Min Before Naproxen Sodium Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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 Number of Participants Analyzed 13 14 15 13 10 15
Mean (95% Confidence Interval)
Unit of Measure: percentage
Day 7 at 1 hour
99.86 [1] 
(99.82 to NA)
99.83 [1] 
(99.81 to NA)
99.69 [1] 
(99.63 to NA)
99.67 [1] 
(99.60 to NA)
99.91 [1] 
(99.87 to NA)
99.84 [1] 
(99.81 to NA)
Day 7 at 3 hour
99.84 [1] 
(99.79 to NA)
99.79 [1] 
(99.76 to NA)
99.54 [1] 
(99.46 to NA)
99.66 [1] 
(99.58 to NA)
99.86 [1] 
(99.81 to NA)
99.80 [1] 
(99.77 to NA)
Day 7 at 6 hour
99.69 [1] 
(99.58 to NA)
99.67 [1] 
(99.60 to NA)
99.44 [1] 
(99.34 to NA)
99.48 [1] 
(99.36 to NA)
99.75 [1] 
(99.63 to NA)
99.70 [1] 
(99.65 to NA)
Day 7 at 12 hour
99.59 [1] 
(99.46 to NA)
99.48 [1] 
(99.42 to NA)
99.12 [1] 
(98.98 to NA)
99.31 [1] 
(99.17 to NA)
99.68 [1] 
(99.57 to NA)
99.63 [1] 
(99.56 to NA)
Day 7 at 18 hour
99.18 [1] 
(99.01 to NA)
99.18 [1] 
(99.04 to NA)
99.76 [1] 
(99.71 to NA)
98.86 [1] 
(98.68 to NA)
99.39 [1] 
(99.19 to NA)
99.70 [1] 
(99.64 to NA)
Day 7 at 24 hour
99.01 [1] 
(98.76 to NA)
99.55 [1] 
(99.43 to NA)
97.78 [1] 
(96.51 to NA)
98.71 [1] 
(98.46 to NA)
99.23 [1] 
(99.00 to NA)
99.80 [1] 
(99.75 to NA)
Day 16 at 1 hour
99.06 [1] 
(98.79 to NA)
98.38 [1] 
(98.10 to NA)
98.32 [1] 
(98.09 to NA)
99.71 [1] 
(99.64 to NA)
99.28 [1] 
(99.08 to NA)
98.81 [1] 
(98.59 to NA)
Day 16 at 3 hour
98.80 [1] 
(98.49 to NA)
97.67 [1] 
(97.41 to NA)
98.02 [1] 
(97.68 to NA)
99.68 [1] 
(99.60 to NA)
99.19 [1] 
(99.00 to NA)
98.53 [1] 
(98.23 to NA)
Day 16 at 6 hour
97.69 [1] 
(97.21 to NA)
96.26 [1] 
(95.70 to NA)
97.40 [1] 
(97.03 to NA)
99.55 [1] 
(99.45 to NA)
98.43 [1] 
(98.05 to NA)
97.51 [1] 
(97.10 to NA)
Day 16 at 12 hour
96.59 [1] 
(95.67 to NA)
92.71 [1] 
(91.13 to NA)
96.31 [1] 
(95.68 to NA)
99.42 [1] 
(99.29 to NA)
97.84 [1] 
(97.10 to NA)
95.38 [1] 
(94.13 to NA)
Day 16 at 18 hour
94.19 [1] 
(93.04 to NA)
92.23 [1] 
(90.24 to NA)
95.68 [1] 
(94.62 to NA)
99.01 [1] 
(98.85 to NA)
96.45 [1] 
(95.43 to NA)
97.73 [1] 
(97.28 to NA)
Day 17 at 1 hour
95.71 [1] 
(94.31 to NA)
94.63 [1] 
(93.66 to NA)
95.56 [1] 
(94.69 to NA)
99.70 [1] 
(99.64 to NA)
97.42 [1] 
(96.88 to NA)
96.95 [1] 
(96.30 to NA)
Day 17 at 3 hour
95.49 [1] 
(94.38 to NA)
92.79 [1] 
(91.36 to NA)
96.43 [1] 
(95.89 to NA)
99.68 [1] 
(99.60 to NA)
96.96 [1] 
(96.33 to NA)
95.92 [1] 
(95.03 to NA)
Day 17 at 6 hour
93.55 [1] 
(91.86 to NA)
90.91 [1] 
(89.21 to NA)
95.64 [1] 
(94.92 to NA)
99.52 [1] 
(99.41 to NA)
95.31 [1] 
(94.32 to NA)
93.91 [1] 
(92.61 to NA)
Day 17 at 12 hour
92.54 [1] 
(91.08 to NA)
91.15 [1] 
(89.80 to NA)
94.13 [1] 
(93.08 to NA)
99.30 [1] 
(99.13 to NA)
94.74 [1] 
(93.62 to NA)
92.60 [1] 
(90.92 to NA)
Day 17 at 18 hour
89.44 [1] 
(87.48 to NA)
87.19 [1] 
(85.43 to NA)
94.23 [1] 
(93.42 to NA)
98.95 [1] 
(98.76 to NA)
93.42 [1] 
(92.27 to NA)
88.14 [1] 
(85.42 to NA)
Day 17 at 24 hour
89.05 [1] 
(86.86 to NA)
83.67 [1] 
(81.77 to NA)
90.39 [1] 
(88.57 to NA)
98.70 [1] 
(98.48 to NA)
91.40 [1] 
(89.21 to NA)
84.27 [1] 
(80.66 to NA)
Day 19 at 1 hour
98.35 [1] 
(97.86 to NA)
97.89 [1] 
(97.45 to NA)
98.89 [1] 
(98.64 to NA)
99.69 [1] 
(99.62 to NA)
98.16 [1] 
(97.74 to NA)
94.06 [1] 
(92.59 to NA)
Day 19 at 3 hour
98.52 [1] 
(98.02 to NA)
97.90 [1] 
(97.46 to NA)
99.05 [1] 
(98.93 to NA)
99.64 [1] 
(99.55 to NA)
98.27 [1] 
(97.92 to NA)
94.44 [1] 
(92.92 to NA)
Day 19 at 6 hour
98.26 [1] 
(97.78 to NA)
97.43 [1] 
(96.73 to NA)
98.98 [1] 
(98.81 to NA)
99.50 [1] 
(99.39 to NA)
97.84 [1] 
(97.34 to NA)
93.25 [1] 
(91.11 to NA)
Day 19 at 12 hour
97.67 [1] 
(96.95 to NA)
96.90 [1] 
(96.06 to NA)
98.77 [1] 
(98.57 to NA)
99.26 [1] 
(99.09 to NA)
97.33 [1] 
(96.70 to NA)
92.00 [1] 
(89.44 to NA)
Day 19 at 18 hour
97.21 [1] 
(96.40 to NA)
96.29 [1] 
(95.40 to NA)
98.52 [1] 
(98.27 to NA)
98.88 [1] 
(98.67 to NA)
96.62 [1] 
(95.86 to NA)
90.94 [1] 
(88.41 to NA)
Day 19 at 24 hour
97.04 [1] 
(96.13 to NA)
96.16 [1] 
(95.25 to NA)
97.98 [1] 
(97.72 to NA)
98.49 [1] 
(98.19 to NA)
96.01 [1] 
(94.86 to NA)
90.67 [1] 
(88.25 to NA)
[1]
One-sided 95% CI
3.Secondary Outcome
Title 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
Hide Description 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.
Time Frame At 1, 3, 6, 12, 18, and 24 hours on Days 7, 16, 17, and 19
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1-IR ASA Co-administered With Naproxen Sodium Group 2-IR ASA 30 Min After Naproxen Sodium Group 3-IR ASA 8 Hours After Naproxen Sodium Group 4-IR ASA Only Group 5-IR ASA 30 Min Before Naproxen Sodium Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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 Number of Participants Analyzed 13 14 15 13 10 14
Mean (95% Confidence Interval)
Unit of Measure: percentage
Day 7 at 1 hour
58.60 [1] 
(29.49 to NA)
12.78 [1] 
(-53.40 to NA)
5.55 [1] 
(-133.79 to NA)
87.73 [1] 
(83.18 to NA)
64.14 [1] 
(40.73 to NA)
30.45 [1] 
(-56.12 to NA)
Day 7 at 3 hour
-121.76 [1] 
(-433.56 to NA)
12.86 [1] 
(-55.68 to NA)
10.80 [1] 
(-116.72 to NA)
79.16 [1] 
(64.67 to NA)
75.89 [1] 
(61.94 to NA)
18.99 [1] 
(-86.18 to NA)
Day 7 at 6 hour
61.74 [1] 
(30.40 to NA)
1.70 [1] 
(-78.01 to NA)
-3.29 [1] 
(-154.22 to NA)
78.20 [1] 
(61.86 to NA)
73.69 [1] 
(55.22 to NA)
26.91 [1] 
(-60.00 to NA)
Day 7 at 12 hour
36.41 [1] 
(-43.85 to NA)
28.54 [1] 
(-24.98 to NA)
-17.95 [1] 
(-143.38 to NA)
80.81 [1] 
(64.37 to NA)
76.02 [1] 
(60.52 to NA)
17.11 [1] 
(-101.18 to NA)
Day 7 at 18 hour
62.36 [1] 
(28.56 to NA)
25.27 [1] 
(-31.41 to NA)
11.96 [1] 
(-115.70 to NA)
78.50 [1] 
(59.88 to NA)
38.58 [1] 
(-41.83 to NA)
-151.06 [1] 
(-559.72 to NA)
Day 7 at 24 hour
80.60 [1] 
(67.50 to NA)
46.31 [1] 
(2.80 to NA)
41.29 [1] 
(-39.70 to NA)
89.12 [1] 
(79.96 to NA)
77.61 [1] 
(60.57 to NA)
44.02 [1] 
(-30.51 to NA)
Day 16 at 1 hour
68.96 [1] 
(49.36 to NA)
24.15 [1] 
(-38.58 to NA)
29.25 [1] 
(-75.23 to NA)
86.12 [1] 
(75.38 to NA)
62.67 [1] 
(29.27 to NA)
45.12 [1] 
(-28.08 to NA)
Day 16 at 3 hour
75.25 [1] 
(54.21 to NA)
51.22 [1] 
(15.81 to NA)
33.12 [1] 
(-59.52 to NA)
85.92 [1] 
(75.16 to NA)
83.51 [1] 
(70.77 to NA)
37.09 [1] 
(-43.70 to NA)
Day 16 at 6 hour
74.45 [1] 
(53.35 to NA)
61.20 [1] 
(31.22 to NA)
62.32 [1] 
(16.46 to NA)
81.36 [1] 
(62.86 to NA)
82.55 [1] 
(72.18 to NA)
81.07 [1] 
(68.49 to NA)
Day 16 at 12 hour
79.88 [1] 
(66.81 to NA)
70.98 [1] 
(46.61 to NA)
11.16 [1] 
(-104.37 to NA)
81.38 [1] 
(65.82 to NA)
79.51 [1] 
(67.21 to NA)
53.04 [1] 
(-2.96 to NA)
Day 16 at 18 hour
73.86 [1] 
(55.68 to NA)
74.07 [1] 
(54.92 to NA)
35.43 [1] 
(-57.37 to NA)
85.19 [1] 
(72.45 to NA)
71.93 [1] 
(41.44 to NA)
71.64 [1] 
(46.97 to NA)
Day 16 at 24 hour
67.47 [1] 
(48.95 to NA)
64.26 [1] 
(40.10 to NA)
15.96 [1] 
(-112.22 to NA)
85.25 [1] 
(75.93 to NA)
73.73 [1] 
(54.81 to NA)
51.40 [1] 
(-3.73 to NA)
Day 17 at 1 hour
76.23 [1] 
(60.92 to NA)
56.77 [1] 
(26.57 to NA)
-452.48 [1] 
(-1402.05 to NA)
83.53 [1] 
(70.94 to NA)
82.13 [1] 
(70.90 to NA)
33.64 [1] 
(-59.65 to NA)
Day 17 at 3 hour
78.48 [1] 
(64.66 to NA)
46.16 [1] 
(8.71 to NA)
21.74 [1] 
(-94.56 to NA)
83.48 [1] 
(70.89 to NA)
75.15 [1] 
(57.21 to NA)
48.27 [1] 
(-7.35 to NA)
Day 17 at 6 hour
76.46 [1] 
(58.65 to NA)
69.16 [1] 
(48.57 to NA)
37.52 [1] 
(-55.41 to NA)
83.48 [1] 
(70.87 to NA)
74.61 [1] 
(52.27 to NA)
52.03 [1] 
(-10.17 to NA)
Day 17 at 12 hour
83.17 [1] 
(73.08 to NA)
86.40 [1] 
(77.88 to NA)
-24.72 [1] 
(-210.72 to NA)
86.00 [1] 
(77.13 to NA)
82.37 [1] 
(66.62 to NA)
67.55 [1] 
(29.95 to NA)
Day 17 at 18 hour
82.30 [1] 
(71.15 to NA)
68.65 [1] 
(46.96 to NA)
31.96 [1] 
(-49.12 to NA)
83.71 [1] 
(71.17 to NA)
71.35 [1] 
(52.97 to NA)
41.51 [1] 
(-26.81 to NA)
Day 17 at 24 hour
78.66 [1] 
(60.37 to NA)
70.84 [1] 
(48.77 to NA)
53.24 [1] 
(6.29 to NA)
85.43 [1] 
(72.64 to NA)
82.13 [1] 
(65.15 to NA)
87.02 [1] 
(75.80 to NA)
Day 19 at 1 hour
64.06 [1] 
(32.28 to NA)
41.10 [1] 
(-8.04 to NA)
21.46 [1] 
(-94.72 to NA)
83.97 [1] 
(71.42 to NA)
81.05 [1] 
(69.60 to NA)
43.92 [1] 
(-30.71 to NA)
Day 19 at 3 hour
69.18 [1] 
(40.13 to NA)
48.51 [1] 
(13.80 to NA)
23.64 [1] 
(-80.27 to NA)
81.62 [1] 
(65.10 to NA)
78.01 [1] 
(62.78 to NA)
14.85 [1] 
(-110.07 to NA)
Day 19 at 6 hour
60.96 [1] 
(25.06 to NA)
50.21 [1] 
(13.65 to NA)
51.59 [1] 
(-6.05 to NA)
82.98 [1] 
(68.39 to NA)
70.87 [1] 
(50.28 to NA)
58.64 [1] 
(8.83 to NA)
Day 19 at 12 hour
1.08 [1] 
(-154.10 to NA)
33.43 [1] 
(-18.68 to NA)
36.92 [1] 
(-56.02 to NA)
84.45 [1] 
(71.72 to NA)
44.97 [1] 
(-20.01 to NA)
13.17 [1] 
(-88.62 to NA)
Day 19 at 18 hour
69.69 [1] 
(41.06 to NA)
74.55 [1] 
(52.71 to NA)
15.41 [1] 
(-112.49 to NA)
91.12 [1] 
(88.88 to NA)
88.43 [1] 
(82.08 to NA)
84.46 [1] 
(70.88 to NA)
Day 19 at 24 hour
89.86 [1] 
(83.15 to NA)
80.90 [1] 
(67.49 to NA)
29.02 [1] 
(-75.60 to NA)
83.67 [1] 
(66.77 to NA)
82.63 [1] 
(70.80 to NA)
71.27 [1] 
(44.27 to NA)
[1]
One-sided 95% CI
4.Secondary Outcome
Title 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
Hide Description 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.
Time Frame At 1, 3, 6, 12, 18, and 24 hours on Days 7, 16, 17, and 19
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1-IR ASA Co-administered With Naproxen Sodium Group 2-IR ASA 30 Min After Naproxen Sodium Group 3-IR ASA 8 Hours After Naproxen Sodium Group 4-IR ASA Only Group 5-IR ASA 30 Min Before Naproxen Sodium Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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 Number of Participants Analyzed 13 14 15 13 10 15
Mean (95% Confidence Interval)
Unit of Measure: percentage
Day 7 at 1 hour
98.84 [1] 
(98.35 to NA)
98.82 [1] 
(98.33 to NA)
97.59 [1] 
(96.62 to NA)
98.34 [1] 
(97.61 to NA)
99.40 [1] 
(99.17 to NA)
98.67 [1] 
(98.14 to NA)
Day 7 at 3 hour
97.82 [1] 
(97.00 to NA)
98.25 [1] 
(97.48 to NA)
97.72 [1] 
(97.03 to NA)
97.61 [1] 
(96.55 to NA)
98.95 [1] 
(98.49 to NA)
97.68 [1] 
(96.44 to NA)
Day 7 at 6 hour
97.95 [1] 
(96.59 to NA)
98.57 [1] 
(97.83 to NA)
98.37 [1] 
(97.63 to NA)
97.29 [1] 
(96.46 to NA)
99.06 [1] 
(98.42 to NA)
97.93 [1] 
(97.29 to NA)
Day 7 at 12 hour
97.75 [1] 
(96.69 to NA)
97.92 [1] 
(96.72 to NA)
96.66 [1] 
(95.59 to NA)
97.49 [1] 
(96.71 to NA)
98.54 [1] 
(97.70 to NA)
98.36 [1] 
(97.52 to NA)
Day 7 at 18 hour
97.85 [1] 
(96.65 to NA)
96.09 [1] 
(94.63 to NA)
98.79 [1] 
(98.32 to NA)
96.29 [1] 
(94.83 to NA)
97.97 [1] 
(96.94 to NA)
97.87 [1] 
(96.98 to NA)
Day 7 at 24 hour
96.62 [1] 
(95.38 to NA)
98.26 [1] 
(97.59 to NA)
98.89 [1] 
(98.42 to NA)
95.04 [1] 
(93.35 to NA)
98.13 [1] 
(97.54 to NA)
98.44 [1] 
(97.81 to NA)
Day 16 at 1 hour
98.06 [1] 
(97.15 to NA)
95.49 [1] 
(93.79 to NA)
89.55 [1] 
(87.09 to NA)
98.99 [1] 
(98.59 to NA)
96.73 [1] 
(95.54 to NA)
94.95 [1] 
(92.99 to NA)
Day 16 at 3 hour
93.03 [1] 
(90.35 to NA)
89.25 [1] 
(85.98 to NA)
92.62 [1] 
(90.24 to NA)
97.37 [1] 
(96.45 to NA)
96.17 [1] 
(95.16 to NA)
90.62 [1] 
(87.59 to NA)
Day 16 at 6 hour
93.55 [1] 
(89.83 to NA)
88.62 [1] 
(83.96 to NA)
90.40 [1] 
(88.30 to NA)
98.50 [1] 
(97.89 to NA)
95.56 [1] 
(93.74 to NA)
91.27 [1] 
(87.89 to NA)
Day 16 at 12 hour
89.55 [1] 
(86.80 to NA)
85.63 [1] 
(80.50 to NA)
88.76 [1] 
(85.89 to NA)
97.42 [1] 
(96.77 to NA)
92.30 [1] 
(90.55 to NA)
89.45 [1] 
(84.52 to NA)
Day 16 at 18 hour
86.61 [1] 
(82.69 to NA)
84.41 [1] 
(80.03 to NA)
82.14 [1] 
(75.75 to NA)
95.69 [1] 
(94.57 to NA)
93.28 [1] 
(91.00 to NA)
91.03 [1] 
(87.81 to NA)
Day 16 at 24 hour
86.42 [1] 
(80.81 to NA)
72.66 [1] 
(65.53 to NA)
77.71 [1] 
(72.15 to NA)
95.78 [1] 
(94.35 to NA)
88.49 [1] 
(84.08 to NA)
86.87 [1] 
(81.86 to NA)
Day 17 at 1 hour
86.19 [1] 
(80.48 to NA)
79.99 [1] 
(74.59 to NA)
86.14 [1] 
(83.15 to NA)
98.72 [1] 
(98.30 to NA)
93.75 [1] 
(91.26 to NA)
90.00 [1] 
(84.47 to NA)
Day 17 at 3 hour
85.45 [1] 
(79.85 to NA)
90.16 [1] 
(87.39 to NA)
92.60 [1] 
(90.38 to NA)
98.01 [1] 
(97.13 to NA)
88.52 [1] 
(84.47 to NA)
83.94 [1] 
(78.25 to NA)
Day 17 at 6 hour
82.90 [1] 
(75.87 to NA)
84.77 [1] 
(80.99 to NA)
83.08 [1] 
(77.53 to NA)
97.34 [1] 
(96.57 to NA)
92.39 [1] 
(89.45 to NA)
85.82 [1] 
(79.55 to NA)
Day 17 at 12 hour
83.49 [1] 
(76.38 to NA)
81.22 [1] 
(75.88 to NA)
86.50 [1] 
(82.09 to NA)
97.46 [1] 
(96.40 to NA)
92.42 [1] 
(88.90 to NA)
82.13 [1] 
(76.07 to NA)
Day 17 at 18 hour
85.77 [1] 
(81.67 to NA)
78.34 [1] 
(72.79 to NA)
86.53 [1] 
(82.83 to NA)
95.47 [1] 
(93.79 to NA)
85.70 [1] 
(82.50 to NA)
70.90 [1] 
(62.89 to NA)
Day 17 at 24 hour
79.55 [1] 
(72.74 to NA)
79.06 [1] 
(72.89 to NA)
75.67 [1] 
(70.44 to NA)
97.23 [1] 
(96.19 to NA)
92.07 [1] 
(89.87 to NA)
81.34 [1] 
(76.55 to NA)
Day 19 at 1 hour
92.68 [1] 
(89.50 to NA)
89.65 [1] 
(86.17 to NA)
95.32 [1] 
(93.74 to NA)
98.05 [1] 
(97.37 to NA)
94.39 [1] 
(91.69 to NA)
79.36 [1] 
(73.75 to NA)
Day 19 at 3 hour
91.03 [1] 
(88.18 to NA)
92.04 [1] 
(90.13 to NA)
93.68 [1] 
(91.71 to NA)
97.82 [1] 
(97.16 to NA)
94.53 [1] 
(91.78 to NA)
79.82 [1] 
(74.39 to NA)
Day 19 at 6 hour
90.57 [1] 
(87.64 to NA)
91.49 [1] 
(88.95 to NA)
92.35 [1] 
(90.34 to NA)
98.24 [1] 
(97.66 to NA)
93.72 [1] 
(90.55 to NA)
81.14 [1] 
(77.02 to NA)
Day 19 at 12 hour
91.59 [1] 
(88.31 to NA)
89.25 [1] 
(86.51 to NA)
95.18 [1] 
(93.46 to NA)
96.91 [1] 
(95.87 to NA)
92.84 [1] 
(90.52 to NA)
80.66 [1] 
(75.32 to NA)
Day 19 at 18 hour
91.20 [1] 
(87.58 to NA)
93.50 [1] 
(91.00 to NA)
94.85 [1] 
(92.96 to NA)
96.24 [1] 
(95.27 to NA)
92.74 [1] 
(89.92 to NA)
85.67 [1] 
(81.17 to NA)
Day 19 at 24 hour
93.76 [1] 
(91.18 to NA)
90.93 [1] 
(87.80 to NA)
93.66 [1] 
(91.58 to NA)
96.63 [1] 
(95.39 to NA)
96.14 [1] 
(93.74 to NA)
81.67 [1] 
(74.94 to NA)
[1]
One-sided 95% CI
Time Frame Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Adverse Event Reporting Description 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.
 
Arm/Group Title Group 0-IR ASA 81 mg qd in Run-in Period Group 1-IR ASA Co-administered With Naproxen Sodium Group 2-IR ASA 30 Min After Naproxen Sodium Group 3-IR ASA 8 Hours After Naproxen Sodium Group 4-IR ASA Only Group 5-IR ASA 30 Min Before Naproxen Sodium Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid
Hide Arm/Group Description 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. 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. 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. 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. 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. 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. 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.
All-Cause Mortality
Group 0-IR ASA 81 mg qd in Run-in Period Group 1-IR ASA Co-administered With Naproxen Sodium Group 2-IR ASA 30 Min After Naproxen Sodium Group 3-IR ASA 8 Hours After Naproxen Sodium Group 4-IR ASA Only Group 5-IR ASA 30 Min Before Naproxen Sodium Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Group 0-IR ASA 81 mg qd in Run-in Period Group 1-IR ASA Co-administered With Naproxen Sodium Group 2-IR ASA 30 Min After Naproxen Sodium Group 3-IR ASA 8 Hours After Naproxen Sodium Group 4-IR ASA Only Group 5-IR ASA 30 Min Before Naproxen Sodium Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/102 (0.00%)   0/17 (0.00%)   0/17 (0.00%)   0/17 (0.00%)   0/17 (0.00%)   0/17 (0.00%)   0/17 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group 0-IR ASA 81 mg qd in Run-in Period Group 1-IR ASA Co-administered With Naproxen Sodium Group 2-IR ASA 30 Min After Naproxen Sodium Group 3-IR ASA 8 Hours After Naproxen Sodium Group 4-IR ASA Only Group 5-IR ASA 30 Min Before Naproxen Sodium Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/102 (0.00%)   4/17 (23.53%)   1/17 (5.88%)   4/17 (23.53%)   3/17 (17.65%)   2/17 (11.76%)   4/17 (23.53%) 
Ear and labyrinth disorders               
Ear pain * 1  0/102 (0.00%)  1/17 (5.88%)  0/17 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  0/17 (0.00%) 
Gastrointestinal disorders               
Diarrhoea * 1  0/102 (0.00%)  0/17 (0.00%)  1/17 (5.88%)  0/17 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  0/17 (0.00%) 
Frequent bowel movements * 1  0/102 (0.00%)  0/17 (0.00%)  1/17 (5.88%)  0/17 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  0/17 (0.00%) 
Infrequent bowel movements * 1  0/102 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  1/17 (5.88%)  1/17 (5.88%)  0/17 (0.00%)  2/17 (11.76%) 
Nausea * 1  0/102 (0.00%)  1/17 (5.88%)  0/17 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  0/17 (0.00%) 
Rectal haemorrhage * 1  0/102 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  1/17 (5.88%) 
General disorders               
Chest discomfort * 1  0/102 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  1/17 (5.88%)  0/17 (0.00%) 
Fatigue * 1  0/102 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  1/17 (5.88%)  0/17 (0.00%)  0/17 (0.00%)  0/17 (0.00%) 
Vessel puncture site bruise * 1  0/102 (0.00%)  1/17 (5.88%)  0/17 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  0/17 (0.00%) 
Injury, poisoning and procedural complications               
Contusion * 1  0/102 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  1/17 (5.88%)  0/17 (0.00%)  0/17 (0.00%)  0/17 (0.00%) 
Investigations               
Coagulation time prolonged * 1  0/102 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  1/17 (5.88%) 
Musculoskeletal and connective tissue disorders               
Musculoskeletal chest pain * 1  0/102 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  1/17 (5.88%)  0/17 (0.00%)  0/17 (0.00%) 
Nervous system disorders               
Dizziness * 1  0/102 (0.00%)  1/17 (5.88%)  0/17 (0.00%)  0/17 (0.00%)  1/17 (5.88%)  0/17 (0.00%)  1/17 (5.88%) 
Syncope * 1  0/102 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  1/17 (5.88%)  0/17 (0.00%)  0/17 (0.00%) 
Reproductive system and breast disorders               
Dysmenorrhoea * 1  0/102 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  1/17 (5.88%)  0/17 (0.00%)  0/17 (0.00%)  0/17 (0.00%) 
Pelvic discomfort * 1  0/102 (0.00%)  1/17 (5.88%)  0/17 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  0/17 (0.00%) 
Skin and subcutaneous tissue disorders               
Dry skin * 1  0/102 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  1/17 (5.88%)  0/17 (0.00%)  0/17 (0.00%)  0/17 (0.00%) 
Skin irritation * 1  0/102 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  1/17 (5.88%)  0/17 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (18.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Name/Title: Therapeutic Area Head
Organization: BAYER
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02229461     History of Changes
Other Study ID Numbers: 15525
First Submitted: July 31, 2014
First Posted: September 1, 2014
Results First Submitted: May 4, 2016
Results First Posted: June 10, 2016
Last Update Posted: July 15, 2016