Trial Outcomes & Findings for Prasugrel/Clopidogrel Maintenance Dose Washout Study (NCT NCT01014624)
NCT ID: NCT01014624
Last Updated: 2021-06-28
Results Overview
On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hours (+/- 6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the participant met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/(Baseline PRU) less than or equal to 20%. The results are expressed as cumulative percentage of participants.
COMPLETED
PHASE4
56 participants
up to 12 days after last dose
2021-06-28
Participant Flow
Participants were recruited at 4 sites in the US from 23 February 2010 to 24 May 2010 and 56 participants were randomized into the study. The study population consisted of male and female aspirin-treated participants with stable coronary artery disease, 18 to 75 years of age.
The Overall Study Period included a 1-day to 14-day Screening Period, a 7-day Active Treatment Period, and a Washout Period of up to 12 days. Following the 1-day to 14-day Screening Period, eligible participants were randomized in a 1:1 ratio to either prasugrel or clopidogrel at Visit 2 (the first day of the Active Treatment Period).
Participant milestones
| Measure |
Prasugrel
Prasugrel 10mg tablet administered once daily for 7 days followed by a Washout Period up to 12 days.
|
Clopidogrel
Clopidogrel 75 mg tablet administered once daily for 7 days followed by Washout Period up to 12 days.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
27
|
|
Overall Study
COMPLETED
|
27
|
26
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Prasugrel
Prasugrel 10mg tablet administered once daily for 7 days followed by a Washout Period up to 12 days.
|
Clopidogrel
Clopidogrel 75 mg tablet administered once daily for 7 days followed by Washout Period up to 12 days.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Prasugrel/Clopidogrel Maintenance Dose Washout Study
Baseline characteristics by cohort
| Measure |
Prasugrel
n=29 Participants
Prasugrel 10mg tablet administered once daily for 7 days followed by a Washout Period up to 12 days.
|
Clopidogrel
n=27 Participants
Clopidogrel 75 mg tablet administered once daily for 7 days followed by Washout Period up to 12 days.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.5 Years
STANDARD_DEVIATION 8.45 • n=5 Participants
|
62.3 Years
STANDARD_DEVIATION 8.10 • n=7 Participants
|
59.80 Years
STANDARD_DEVIATION 8.56 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
weight
|
97.3 kg
STANDARD_DEVIATION 15.13 • n=5 Participants
|
90.8 kg
STANDARD_DEVIATION 14.41 • n=7 Participants
|
94.1 kg
STANDARD_DEVIATION 15.02 • n=5 Participants
|
|
Height
|
174.1 cm
STANDARD_DEVIATION 8.20 • n=5 Participants
|
173.5 cm
STANDARD_DEVIATION 9.00 • n=7 Participants
|
173.8 cm
STANDARD_DEVIATION 8.52 • n=5 Participants
|
|
Ethnicity
Hispanic or Latino
|
1 participants
0 • n=5 Participants
|
0 participants
0 • n=7 Participants
|
1 participants
0 • n=5 Participants
|
|
Ethnicity
Non Hispanic or Latino
|
28 participants
0 • n=5 Participants
|
27 participants
0 • n=7 Participants
|
55 participants
0 • n=5 Participants
|
|
Body Mass Index
|
32.0 kg/m^2
STANDARD_DEVIATION 4.07 • n=5 Participants
|
30.3 kg/m^2
STANDARD_DEVIATION 5.34 • n=7 Participants
|
31.2 kg/m^2
STANDARD_DEVIATION 4.76 • n=5 Participants
|
|
Smoking Status
Never smoked
|
7 participants
0 • n=5 Participants
|
10 participants
0 • n=7 Participants
|
17 participants
0 • n=5 Participants
|
|
Smoking Status
Currently Smoke
|
10 participants
0 • n=5 Participants
|
6 participants
0 • n=7 Participants
|
16 participants
0 • n=5 Participants
|
|
Smoking Status
Formerly Smoked
|
12 participants
0 • n=5 Participants
|
11 participants
0 • n=7 Participants
|
23 participants
0 • n=5 Participants
|
|
Alcohol Use
Never used alcohol
|
3 participants
0 • n=5 Participants
|
5 participants
0 • n=7 Participants
|
8 participants
0 • n=5 Participants
|
|
Alcohol Use
Currently use alcohol
|
19 participants
0 • n=5 Participants
|
18 participants
0 • n=7 Participants
|
37 participants
0 • n=5 Participants
|
|
Alcohol Use
Formerly used alcohol
|
7 participants
0 • n=5 Participants
|
4 participants
0 • n=7 Participants
|
11 participants
0 • n=5 Participants
|
|
Diabetes status
Does not have diabetes
|
18 participants
0 • n=5 Participants
|
16 participants
0 • n=7 Participants
|
34 participants
0 • n=5 Participants
|
|
Diabetes status
Has diabetes
|
11 participants
0 • n=5 Participants
|
11 participants
0 • n=7 Participants
|
22 participants
0 • n=5 Participants
|
PRIMARY outcome
Timeframe: up to 12 days after last dosePopulation: Participants in Primary Population defined as Baseline PRU-PRU less than or equal to 60 units (R-to-B). Primary Population included participants who entered Washout Period and had platelet function data at both baseline and Washout Period Day 1.
On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hours (+/- 6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the participant met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/(Baseline PRU) less than or equal to 20%. The results are expressed as cumulative percentage of participants.
Outcome measures
| Measure |
Prasugrel
n=28 Participants
Prasugrel 10mg tablet administered once daily for 7 days followed by a Washout period up to 12 days.
|
Clopidogrel
n=26 Participants
Clopidogrel 75 mg tablet administered once daily for 7 days followed by Washout period up to 12 days.
|
|---|---|---|
|
The Time to Return to Baseline Platelet Function as Assessed by P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNOW P2Y12 Device Based on the Primary Definition of Return to Baseline
return to baseline PRU by washout day 1
|
0 cumulative percentage of participants
|
30.8 cumulative percentage of participants
|
|
The Time to Return to Baseline Platelet Function as Assessed by P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNOW P2Y12 Device Based on the Primary Definition of Return to Baseline
return to baseline PRU by washout day 3
|
3.6 cumulative percentage of participants
|
53.9 cumulative percentage of participants
|
|
The Time to Return to Baseline Platelet Function as Assessed by P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNOW P2Y12 Device Based on the Primary Definition of Return to Baseline
return to baseline PRU by washout day 5
|
37.0 cumulative percentage of participants
|
84.6 cumulative percentage of participants
|
|
The Time to Return to Baseline Platelet Function as Assessed by P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNOW P2Y12 Device Based on the Primary Definition of Return to Baseline
return to baseline PRU by washout day 6
|
62.9 cumulative percentage of participants
|
96.2 cumulative percentage of participants
|
|
The Time to Return to Baseline Platelet Function as Assessed by P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNOW P2Y12 Device Based on the Primary Definition of Return to Baseline
return to baseline PRU by washout day 7
|
77.8 cumulative percentage of participants
|
96.2 cumulative percentage of participants
|
|
The Time to Return to Baseline Platelet Function as Assessed by P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNOW P2Y12 Device Based on the Primary Definition of Return to Baseline
return to baseline PRU by washout day 9
|
100.0 cumulative percentage of participants
|
100.0 cumulative percentage of participants
|
PRIMARY outcome
Timeframe: up to 12 days after last dosePopulation: Participants in Primary Population using secondary definition of return to baseline. Primary Population included participants who entered the Washout Period and had platelet function data at both baseline and Washout Period Day 1. Secondary definition of return to baseline was (Baseline PRU-PRU)/Baseline PRU less than or equal to 20%.
On the first day of the Washout Period (visit 3), the blood draw for platelet function testing was obtained 24 hours (+/- 6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the participant met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/(Baseline PRU) less than or equal to 20%.
Outcome measures
| Measure |
Prasugrel
n=28 Participants
Prasugrel 10mg tablet administered once daily for 7 days followed by a Washout period up to 12 days.
|
Clopidogrel
n=26 Participants
Clopidogrel 75 mg tablet administered once daily for 7 days followed by Washout period up to 12 days.
|
|---|---|---|
|
The Time to Return to Baseline Platelet Function as Assessed by P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNOW P2Y12 Device Based on the Secondary Definition of Return to Baseline
returned to baseline PRU by washout day 1
|
0.0 cumulative percentage of participants
|
30.8 cumulative percentage of participants
|
|
The Time to Return to Baseline Platelet Function as Assessed by P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNOW P2Y12 Device Based on the Secondary Definition of Return to Baseline
returned to baseline PRU by washout day 3
|
0.0 cumulative percentage of participants
|
53.9 cumulative percentage of participants
|
|
The Time to Return to Baseline Platelet Function as Assessed by P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNOW P2Y12 Device Based on the Secondary Definition of Return to Baseline
returned to baseline PRU by washout day 5
|
37.0 cumulative percentage of participants
|
80.8 cumulative percentage of participants
|
|
The Time to Return to Baseline Platelet Function as Assessed by P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNOW P2Y12 Device Based on the Secondary Definition of Return to Baseline
returned to baseline PRU by washout day 6
|
55.6 cumulative percentage of participants
|
88.5 cumulative percentage of participants
|
|
The Time to Return to Baseline Platelet Function as Assessed by P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNOW P2Y12 Device Based on the Secondary Definition of Return to Baseline
returned to baseline PRU by washout day 7
|
77.8 cumulative percentage of participants
|
96.2 cumulative percentage of participants
|
|
The Time to Return to Baseline Platelet Function as Assessed by P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNOW P2Y12 Device Based on the Secondary Definition of Return to Baseline
returned to baseline PRU by washout day 9
|
100.0 cumulative percentage of participants
|
100.0 cumulative percentage of participants
|
SECONDARY outcome
Timeframe: up to 12 days after last dosePopulation: Participants in Primary Population using primary definition of return to baseline. Primary population included participants who entered the Washout Period and had platelet function data at both baseline and Washout Period Day 1. Primary definition of return to baseline was (Baseline PRU-PRU) less than or equal to 60 units.
On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hours (+/-6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the participants met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/Baseline PRU less than or equal to 20%.
Outcome measures
| Measure |
Prasugrel
n=28 Participants
Prasugrel 10mg tablet administered once daily for 7 days followed by a Washout period up to 12 days.
|
Clopidogrel
n=26 Participants
Clopidogrel 75 mg tablet administered once daily for 7 days followed by Washout period up to 12 days.
|
|---|---|---|
|
Day at Which 50%, 75%, and 90% of Participants Returned to Baseline Platelet Function Based on Primary Definition of Return to Baseline Using the Primary Population
Washout day 50% returned to baseline PRU
|
6 days
|
3 days
|
|
Day at Which 50%, 75%, and 90% of Participants Returned to Baseline Platelet Function Based on Primary Definition of Return to Baseline Using the Primary Population
Washout day 75% returned to baseline PRU
|
7 days
|
5 days
|
|
Day at Which 50%, 75%, and 90% of Participants Returned to Baseline Platelet Function Based on Primary Definition of Return to Baseline Using the Primary Population
Washout day 90% returned to baseline PRU
|
9 days
|
6 days
|
SECONDARY outcome
Timeframe: up to 12 days after last dosePopulation: Participants in Primary Population using secondary definition of return to baseline. Primary Population included participants who entered Washout Period and had platelet function data at both baseline and Washout Period Day 1. Secondary definition of return to baseline was (Baseline PRU-PRU)/Baseline PRU less than or equal to 20%.
On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hours (+/-6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the participant met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/Baseline PRU less than or equal to 20%.
Outcome measures
| Measure |
Prasugrel
n=28 Participants
Prasugrel 10mg tablet administered once daily for 7 days followed by a Washout period up to 12 days.
|
Clopidogrel
n=26 Participants
Clopidogrel 75 mg tablet administered once daily for 7 days followed by Washout period up to 12 days.
|
|---|---|---|
|
Day at Which 50%, 75%, and 90% of Participants Returned to Baseline Platelet Function Based on Secondary Definition of Return to Baseline Using the Primary Population
Washout day 50% returned to baseline PRU
|
6 days
|
3 days
|
|
Day at Which 50%, 75%, and 90% of Participants Returned to Baseline Platelet Function Based on Secondary Definition of Return to Baseline Using the Primary Population
Washout day 75% returned to baseline PRU
|
7 days
|
5 days
|
|
Day at Which 50%, 75%, and 90% of Participants Returned to Baseline Platelet Function Based on Secondary Definition of Return to Baseline Using the Primary Population
Washout day 90% returned to baseline PRU
|
9 days
|
7 days
|
SECONDARY outcome
Timeframe: up to 12 days after last dosePopulation: Participants in Responder Population using primary definition of R-to-B. Primary Population included participants who entered Washout Period and had platelet function data at baseline and Washout Day 1. Responder Population was Primary Population excluding poor pharmacodynamic responders. Primary definition of R-to-B was (Baseline PRU-PRU) less than or equal to 60 units.
On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hours (+/-6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the participant met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/Baseline PRU less than or equal to 20%.
Outcome measures
| Measure |
Prasugrel
n=28 Participants
Prasugrel 10mg tablet administered once daily for 7 days followed by a Washout period up to 12 days.
|
Clopidogrel
n=15 Participants
Clopidogrel 75 mg tablet administered once daily for 7 days followed by Washout period up to 12 days.
|
|---|---|---|
|
Day at Which 50%, 75%, and 90% of Participants Returned to Baseline Platelet Function Based on the Primary Definition of Return to Baseline Using the Responder Population
Washout day 50% returned to baseline PRU
|
6 days
|
5 days
|
|
Day at Which 50%, 75%, and 90% of Participants Returned to Baseline Platelet Function Based on the Primary Definition of Return to Baseline Using the Responder Population
Washout day 75% returned to baseline PRU
|
7 days
|
5 days
|
|
Day at Which 50%, 75%, and 90% of Participants Returned to Baseline Platelet Function Based on the Primary Definition of Return to Baseline Using the Responder Population
Washout day 90% returned to baseline PRU
|
9 days
|
6 days
|
SECONDARY outcome
Timeframe: up to 12 days after the last dosePopulation: Participants in Responder Population using secondary definition of R-to-B. Primary Population included participants who entered Washout Period and had platelet function data at both baseline and Washout Period Day 1. Responder Population was Primary Population excluding poor pharmacodynamic responders. Secondary definition of R-to-B was (Baseline PRU-PRU)/ (Baseline PRU) \<= 20%.
On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hour (+/- 6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the participant met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/(Baseline PRU) less than or equal to (\<=) 20%.
Outcome measures
| Measure |
Prasugrel
n=28 Participants
Prasugrel 10mg tablet administered once daily for 7 days followed by a Washout period up to 12 days.
|
Clopidogrel
n=15 Participants
Clopidogrel 75 mg tablet administered once daily for 7 days followed by Washout period up to 12 days.
|
|---|---|---|
|
Day at Which 50%, 75%, and 90% of Participants Returned to Baseline Platelet Function Based on the Secondary Definition of Return to Baseline Using the Responder Population
Washout day 50% returned to baseline PRU
|
6 days
|
5 days
|
|
Day at Which 50%, 75%, and 90% of Participants Returned to Baseline Platelet Function Based on the Secondary Definition of Return to Baseline Using the Responder Population
Washout day 75% returned to baseline PRU
|
7 days
|
6 days
|
|
Day at Which 50%, 75%, and 90% of Participants Returned to Baseline Platelet Function Based on the Secondary Definition of Return to Baseline Using the Responder Population
Washout day 90% returned to baseline PRU
|
9 days
|
7 days
|
SECONDARY outcome
Timeframe: Washout Day 1Population: Participants in the Primary Population. The Primary Population included participants who entered the Washout Period and had platelet function testing data at both baseline (Visit 2) and Washout Period Day 1 (Visit 3).
Inhibition of platelet aggregation was assessed by Accumetrics VerifyNow® P2Y12 reaction units (PRU). On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hour (+/- 6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the participant met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/(Baseline PRU) less than or equal to 20%.
Outcome measures
| Measure |
Prasugrel
n=28 Participants
Prasugrel 10mg tablet administered once daily for 7 days followed by a Washout period up to 12 days.
|
Clopidogrel
n=26 Participants
Clopidogrel 75 mg tablet administered once daily for 7 days followed by Washout period up to 12 days.
|
|---|---|---|
|
Percentage of Inhibition of Platelet Aggregation on Washout Day 1
|
72.3 percentage
Standard Deviation 11.78
|
35.4 percentage
Standard Deviation 23.35
|
SECONDARY outcome
Timeframe: up to 12 days after the last dosePopulation: Participants in the Primary Population. The Primary Population included participants who entered the Washout Period and had platelet function testing data at both baseline (Visit 2) and Washout Period Day 1 (Visit 3). The primary definition of return to baseline was (Baseline PRU-PRU) less than or equal to 60 units.
Time to return to baseline PRU (\<= 60 units of baseline) dependent upon baseline PRU and platelet % inhibition on Washout Period Day 1 but independent of treatment. The following regression model was derived for predicting number of days to return to baseline PRU where PI(1) represents platelet percentage inhibition on Washout Day 1. Number days to return to baseline PRU derived from: Number days to return to baseline PRU=-3.350+0.079\*PI(1)+0.014\*baseline PRU. The predicted number of days to return to baseline based on device-derived platelet percentage inhibition is reported for each treatment group.
Outcome measures
| Measure |
Prasugrel
n=28 Participants
Prasugrel 10mg tablet administered once daily for 7 days followed by a Washout period up to 12 days.
|
Clopidogrel
n=26 Participants
Clopidogrel 75 mg tablet administered once daily for 7 days followed by Washout period up to 12 days.
|
|---|---|---|
|
Time to Return to Baseline PRU for the Primary Population Using the Primary Definition of Return to Baseline in Relation to the Inhibition of Platelet Aggregation 24 Hours Following the Last Maintenance Dose
|
6.2 days
|
3.7 days
|
Adverse Events
Prasugrel
Clopidogrel
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Prasugrel
n=29 participants at risk
Prasugrel 10mg tablet administered once daily for 7 days followed by a Washout Period up to 12 days.
|
Clopidogrel
n=27 participants at risk
Clopidogrel 75 mg tablet administered once daily for 7 days followed by Washout Period up to 12 days.
|
|---|---|---|
|
Ear and labyrinth disorders
eyelid oedema
|
3.4%
1/29 • Number of events 1 • Beginning with screening, adverse events (AEs) were assessed at every visit. All AEs occuring after participant signed informed consent and up to 14 days after last dose of study drug were recorded
|
0.00%
0/27 • Beginning with screening, adverse events (AEs) were assessed at every visit. All AEs occuring after participant signed informed consent and up to 14 days after last dose of study drug were recorded
|
|
Gastrointestinal disorders
Adominal discomfort
|
3.4%
1/29 • Number of events 1 • Beginning with screening, adverse events (AEs) were assessed at every visit. All AEs occuring after participant signed informed consent and up to 14 days after last dose of study drug were recorded
|
0.00%
0/27 • Beginning with screening, adverse events (AEs) were assessed at every visit. All AEs occuring after participant signed informed consent and up to 14 days after last dose of study drug were recorded
|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
1/29 • Number of events 1 • Beginning with screening, adverse events (AEs) were assessed at every visit. All AEs occuring after participant signed informed consent and up to 14 days after last dose of study drug were recorded
|
7.4%
2/27 • Number of events 2 • Beginning with screening, adverse events (AEs) were assessed at every visit. All AEs occuring after participant signed informed consent and up to 14 days after last dose of study drug were recorded
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/29 • Beginning with screening, adverse events (AEs) were assessed at every visit. All AEs occuring after participant signed informed consent and up to 14 days after last dose of study drug were recorded
|
3.7%
1/27 • Number of events 1 • Beginning with screening, adverse events (AEs) were assessed at every visit. All AEs occuring after participant signed informed consent and up to 14 days after last dose of study drug were recorded
|
|
General disorders
Pain
|
3.4%
1/29 • Number of events 1 • Beginning with screening, adverse events (AEs) were assessed at every visit. All AEs occuring after participant signed informed consent and up to 14 days after last dose of study drug were recorded
|
0.00%
0/27 • Beginning with screening, adverse events (AEs) were assessed at every visit. All AEs occuring after participant signed informed consent and up to 14 days after last dose of study drug were recorded
|
|
Infections and infestations
nasopharyngitis
|
0.00%
0/29 • Beginning with screening, adverse events (AEs) were assessed at every visit. All AEs occuring after participant signed informed consent and up to 14 days after last dose of study drug were recorded
|
3.7%
1/27 • Number of events 1 • Beginning with screening, adverse events (AEs) were assessed at every visit. All AEs occuring after participant signed informed consent and up to 14 days after last dose of study drug were recorded
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/29 • Beginning with screening, adverse events (AEs) were assessed at every visit. All AEs occuring after participant signed informed consent and up to 14 days after last dose of study drug were recorded
|
3.7%
1/27 • Number of events 1 • Beginning with screening, adverse events (AEs) were assessed at every visit. All AEs occuring after participant signed informed consent and up to 14 days after last dose of study drug were recorded
|
|
Infections and infestations
viral infection
|
3.4%
1/29 • Number of events 1 • Beginning with screening, adverse events (AEs) were assessed at every visit. All AEs occuring after participant signed informed consent and up to 14 days after last dose of study drug were recorded
|
0.00%
0/27 • Beginning with screening, adverse events (AEs) were assessed at every visit. All AEs occuring after participant signed informed consent and up to 14 days after last dose of study drug were recorded
|
|
Metabolism and nutrition disorders
diabetes mellitus
|
0.00%
0/29 • Beginning with screening, adverse events (AEs) were assessed at every visit. All AEs occuring after participant signed informed consent and up to 14 days after last dose of study drug were recorded
|
3.7%
1/27 • Number of events 1 • Beginning with screening, adverse events (AEs) were assessed at every visit. All AEs occuring after participant signed informed consent and up to 14 days after last dose of study drug were recorded
|
|
Nervous system disorders
dizziness
|
3.4%
1/29 • Number of events 1 • Beginning with screening, adverse events (AEs) were assessed at every visit. All AEs occuring after participant signed informed consent and up to 14 days after last dose of study drug were recorded
|
0.00%
0/27 • Beginning with screening, adverse events (AEs) were assessed at every visit. All AEs occuring after participant signed informed consent and up to 14 days after last dose of study drug were recorded
|
|
Nervous system disorders
headache
|
3.4%
1/29 • Number of events 1 • Beginning with screening, adverse events (AEs) were assessed at every visit. All AEs occuring after participant signed informed consent and up to 14 days after last dose of study drug were recorded
|
0.00%
0/27 • Beginning with screening, adverse events (AEs) were assessed at every visit. All AEs occuring after participant signed informed consent and up to 14 days after last dose of study drug were recorded
|
|
Psychiatric disorders
insomnia
|
3.4%
1/29 • Number of events 1 • Beginning with screening, adverse events (AEs) were assessed at every visit. All AEs occuring after participant signed informed consent and up to 14 days after last dose of study drug were recorded
|
3.7%
1/27 • Number of events 1 • Beginning with screening, adverse events (AEs) were assessed at every visit. All AEs occuring after participant signed informed consent and up to 14 days after last dose of study drug were recorded
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
6.9%
2/29 • Number of events 2 • Beginning with screening, adverse events (AEs) were assessed at every visit. All AEs occuring after participant signed informed consent and up to 14 days after last dose of study drug were recorded
|
0.00%
0/27 • Beginning with screening, adverse events (AEs) were assessed at every visit. All AEs occuring after participant signed informed consent and up to 14 days after last dose of study drug were recorded
|
|
Skin and subcutaneous tissue disorders
ecchymosis
|
0.00%
0/29 • Beginning with screening, adverse events (AEs) were assessed at every visit. All AEs occuring after participant signed informed consent and up to 14 days after last dose of study drug were recorded
|
3.7%
1/27 • Number of events 1 • Beginning with screening, adverse events (AEs) were assessed at every visit. All AEs occuring after participant signed informed consent and up to 14 days after last dose of study drug were recorded
|
|
Skin and subcutaneous tissue disorders
increased tendency to bruise
|
6.9%
2/29 • Number of events 2 • Beginning with screening, adverse events (AEs) were assessed at every visit. All AEs occuring after participant signed informed consent and up to 14 days after last dose of study drug were recorded
|
0.00%
0/27 • Beginning with screening, adverse events (AEs) were assessed at every visit. All AEs occuring after participant signed informed consent and up to 14 days after last dose of study drug were recorded
|
|
Gastrointestinal disorders
Adominal pain upper
|
0.00%
0/29 • Beginning with screening, adverse events (AEs) were assessed at every visit. All AEs occuring after participant signed informed consent and up to 14 days after last dose of study drug were recorded
|
3.7%
1/27 • Number of events 1 • Beginning with screening, adverse events (AEs) were assessed at every visit. All AEs occuring after participant signed informed consent and up to 14 days after last dose of study drug were recorded
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place