Trial Outcomes & Findings for Treatment of Refractory Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea/Hypopnea Syndrome (OSA/HS) Using Nasal Continuous Positive Airway Pressure (nCPAP) Therapy (0249-015) (NCT NCT00620659)
NCT ID: NCT00620659
Last Updated: 2015-05-13
Results Overview
The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a patient to remain awake. The primary endpoint was the mean of sleep latency (average of the first 4 MWTs which were at 0900, 1100, 1300, and 1500), where latency for each MWT was defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep was observed according to these rules, then latency was defined as 30 minutes. The comparison was for the mode dose of MK0249 versus placebo.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
125 participants
Primary outcome timeframe
At Week 2
Results posted on
2015-05-13
Participant Flow
The majority of patients were recruited from investigators' own databases at 24 sites in the United States. The primary therapy period was 13-Mar-2008 to 25-Feb-2009.
Participants maintained sleep and sleepiness diaries during a 7- to 10-day placebo run-in period. They used a nasal continuous positive airway pressure (nCPAP) device to monitor their CPAP use. At the end of the run-in period, participants stayed overnight at the clinic for nighttime polysomnography and if eligible, were randomized the next morning
Participant milestones
| Measure |
MK0249/Placebo/Modafinil
Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.
MK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet.
|
Placebo/Modafinil/MK0249
Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.
MK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet.
|
Modafinil/MK0249/Placebo
Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.
MK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet.
|
MK0249/Modafinil/Placebo
Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.
MK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet.
|
Placebo/MK0249/Modafinil
Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.
MK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet.
|
Modafinil/Placebo/MK0249
Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.
MK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet.
|
|---|---|---|---|---|---|---|
|
Treatment Period 1
STARTED
|
21
|
21
|
21
|
21
|
21
|
20
|
|
Treatment Period 1
COMPLETED
|
18
|
21
|
20
|
18
|
20
|
20
|
|
Treatment Period 1
NOT COMPLETED
|
3
|
0
|
1
|
3
|
1
|
0
|
|
Placebo Washout Period 1
STARTED
|
18
|
21
|
20
|
19
|
20
|
20
|
|
Placebo Washout Period 1
COMPLETED
|
18
|
21
|
20
|
18
|
20
|
20
|
|
Placebo Washout Period 1
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Treatment Period 2
STARTED
|
18
|
21
|
20
|
18
|
20
|
20
|
|
Treatment Period 2
COMPLETED
|
18
|
18
|
19
|
18
|
15
|
20
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
3
|
1
|
0
|
5
|
0
|
|
Placebo Washout Period 2
STARTED
|
18
|
18
|
19
|
18
|
15
|
20
|
|
Placebo Washout Period 2
COMPLETED
|
16
|
18
|
19
|
18
|
15
|
20
|
|
Placebo Washout Period 2
NOT COMPLETED
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 3
STARTED
|
16
|
18
|
19
|
18
|
15
|
20
|
|
Treatment Period 3
COMPLETED
|
16
|
16
|
19
|
17
|
15
|
20
|
|
Treatment Period 3
NOT COMPLETED
|
0
|
2
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
MK0249/Placebo/Modafinil
Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.
MK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet.
|
Placebo/Modafinil/MK0249
Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.
MK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet.
|
Modafinil/MK0249/Placebo
Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.
MK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet.
|
MK0249/Modafinil/Placebo
Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.
MK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet.
|
Placebo/MK0249/Modafinil
Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.
MK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet.
|
Modafinil/Placebo/MK0249
Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.
MK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet.
|
|---|---|---|---|---|---|---|
|
Treatment Period 1
Adverse Event
|
1
|
0
|
0
|
3
|
0
|
0
|
|
Treatment Period 1
Protocol Violation
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 1
Withdrawal by Subject
|
1
|
0
|
1
|
0
|
1
|
0
|
|
Placebo Washout Period 1
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Treatment Period 2
Adverse Event
|
0
|
3
|
0
|
0
|
2
|
0
|
|
Treatment Period 2
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
3
|
0
|
|
Placebo Washout Period 2
Adverse Event
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 3
Adverse Event
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Treatment Period 3
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Treatment of Refractory Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea/Hypopnea Syndrome (OSA/HS) Using Nasal Continuous Positive Airway Pressure (nCPAP) Therapy (0249-015)
Baseline characteristics by cohort
| Measure |
All Randomized Participants
n=125 Participants
All participants randomized in study
|
|---|---|
|
Age, Continuous
|
48.6 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
100 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
102 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
19 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Week 2Population: Full Analysis Set (FAS): The FAS population was a subset of all randomized patients with patients excluded for failure to receive at least one dose of study treatment or lack of endpoint data. Patients with at least one dose and endpoint in at least one treatment period were included in the FAS.
The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a patient to remain awake. The primary endpoint was the mean of sleep latency (average of the first 4 MWTs which were at 0900, 1100, 1300, and 1500), where latency for each MWT was defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep was observed according to these rules, then latency was defined as 30 minutes. The comparison was for the mode dose of MK0249 versus placebo.
Outcome measures
| Measure |
Placebo
n=116 Participants
There were 116 participants who received placebo over 3 periods (42, 38, and 36 participants for Periods 1, 2, and 3 respectively).
|
MK0249 Mode Dose
n=39 Participants
The Mode dose (the dose to which most patients were adaptively assigned) of MK0249 was 10 mg.
There were 39 participants who received MK0249 10 mg (Mode Dose) over 3 periods (14, 12, and 13 participants for Periods 1, 2, and 3 respectively).
|
|---|---|---|
|
Mean of Average Maintenance of Wakefulness Test Early for The Mode Dose of MK0249 Versus Placebo
|
12.79 Minutes
Standard Error 0.75
|
13.34 Minutes
Standard Error 1.09
|
SECONDARY outcome
Timeframe: At Week 2Population: Full Analysis Set (FAS): The FAS population was a subset of all randomized patients with patients excluded for failure to receive at least one dose of study treatment or lack of an endpoint data. Patients with at least one dose and endpoint in at least one treatment period were included in the FAS.
The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a patient to remain awake. The primary endpoint was the mean of sleep latency (average of the first 4 MWTs which were at 0900, 1100, 1300, and 1500), where latency for each MWT was defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep was observed according to these rules, then latency was defined as 30 minutes. The comparison was for the mode dose of MK0249 versus modafinil.
Outcome measures
| Measure |
Placebo
n=39 Participants
There were 116 participants who received placebo over 3 periods (42, 38, and 36 participants for Periods 1, 2, and 3 respectively).
|
MK0249 Mode Dose
n=106 Participants
The Mode dose (the dose to which most patients were adaptively assigned) of MK0249 was 10 mg.
There were 39 participants who received MK0249 10 mg (Mode Dose) over 3 periods (14, 12, and 13 participants for Periods 1, 2, and 3 respectively).
|
|---|---|---|
|
Mean of Average Maintenance of Wakefulness Test Early for the Mode Dose of MK0249 Versus Modafinil
|
13.34 Minutes
Standard Error 1.09
|
17.45 Minutes
Standard Error 0.74
|
SECONDARY outcome
Timeframe: At Week 2Population: Full Analysis Set (FAS): The FAS population was a subset of all randomized patients with patients excluded for failure to receive at least one dose of study treatment or lack of an endpoint data. Patients with at least one dose and endpoint in at least one treatment period were included in the FAS.
The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a patient to remain awake. The primary endpoint was the mean of sleep latency (average of the first 4 MWTs which were at 0900, 1100, 1300, and 1500), where latency for each MWT was defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep was observed according to these rules, then latency was defined as 30 minutes. The comparison was for the top 2 doses pooled of MK0249 versus modafinil.
Outcome measures
| Measure |
Placebo
n=74 Participants
There were 116 participants who received placebo over 3 periods (42, 38, and 36 participants for Periods 1, 2, and 3 respectively).
|
MK0249 Mode Dose
n=106 Participants
The Mode dose (the dose to which most patients were adaptively assigned) of MK0249 was 10 mg.
There were 39 participants who received MK0249 10 mg (Mode Dose) over 3 periods (14, 12, and 13 participants for Periods 1, 2, and 3 respectively).
|
|---|---|---|
|
Mean of Average Maintenance of Wakefulness Test Early for Top 2 Doses Pooled of MK0249 Versus Modafinil
|
13.64 Minutes
Standard Error 0.85
|
17.45 Minutes
Standard Error 0.74
|
SECONDARY outcome
Timeframe: At Week 2Population: Full Analysis Set (FAS): The FAS population was a subset of all randomized patients with patients excluded for failure to receive at least one dose of study treatment or lack of an endpoint data. Patients with at least one dose and endpoint in at least one treatment period were included in the FAS.
Clinical Global Impressions Scale of Severity (CGI-S) is a subscale of the CGI which is a standard psychometric scale used to demonstrate changes and improvements in illness. CGI-S consists of a 7-point scale rated from 1 to 7. The investigator or sponsor-approved clinician judged how ill the patient was with respect to Excessive Daytime Sleepiness (EDS) at the time of the CGI-S rating (CGIS-EDS), with higher scores indicating more severe illness.
Outcome measures
| Measure |
Placebo
n=116 Participants
There were 116 participants who received placebo over 3 periods (42, 38, and 36 participants for Periods 1, 2, and 3 respectively).
|
MK0249 Mode Dose
n=39 Participants
The Mode dose (the dose to which most patients were adaptively assigned) of MK0249 was 10 mg.
There were 39 participants who received MK0249 10 mg (Mode Dose) over 3 periods (14, 12, and 13 participants for Periods 1, 2, and 3 respectively).
|
|---|---|---|
|
Clinical Global Impressions Scale of Severity Score as it Relates to Excessive Daytime Sleepiness (CGIS-EDS) for the Mode Dose of MK0249 Versus Placebo
|
3.76 units on a scale
Standard Error 0.11
|
3.43 units on a scale
Standard Error 0.18
|
SECONDARY outcome
Timeframe: At Week 2Population: Full Analysis Set (FAS): The FAS population was a subset of all randomized patients with patients excluded for failure to receive at least one dose of study treatment or lack of an endpoint data. Patients with at least one dose and endpoint in at least one treatment period were included in the FAS.
The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire that provides subjective reports that equate with sleep propensity, not with 'subjective sleepiness'. Having a high sleep propensity means having a history of dozing in situations that have a relatively low soporific nature, in which normal subjects seldom doze. The ESS consists of eight items, which are rated from 0 ("would never dose") to 3 ("high chance of dozing"). The ESS score is the total score of the 8 individual items; this total score ranges from 0 to 24 (higher total score is worse).
Outcome measures
| Measure |
Placebo
n=115 Participants
There were 116 participants who received placebo over 3 periods (42, 38, and 36 participants for Periods 1, 2, and 3 respectively).
|
MK0249 Mode Dose
n=40 Participants
The Mode dose (the dose to which most patients were adaptively assigned) of MK0249 was 10 mg.
There were 39 participants who received MK0249 10 mg (Mode Dose) over 3 periods (14, 12, and 13 participants for Periods 1, 2, and 3 respectively).
|
|---|---|---|
|
Epworth Sleepiness Scale (ESS) Score for the Mode Dose of MK0249 Versus Placebo
|
12.81 units on a scale
Standard Error 0.43
|
10.83 units on a scale
Standard Error 0.65
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 41 other events
Deaths: 0 deaths
MK0249 5 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
MK0249 8 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
MK0249 10 mg
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
MK0249 12 mg
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Modafinil
Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=117 participants at risk
Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet.
|
MK0249 5 mg
n=10 participants at risk
MK0249 was provided as 1 mg and 5 mg tablets.
|
MK0249 8 mg
n=25 participants at risk
MK0249 was provided as 1 mg and 5 mg tablets.
|
MK0249 10 mg
n=46 participants at risk
MK0249 was provided as 1 mg and 5 mg tablets.
|
MK0249 12 mg
n=39 participants at risk
MK0249 was provided as 1 mg and 5 mg tablets.
|
Modafinil
n=111 participants at risk
Modafinil was provided as 100 mg tablets.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Acute pericarditis
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Blood and lymphatic system disorders
Lymph node abscess
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Essential thrombocythaemia
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
Other adverse events
| Measure |
Placebo
n=117 participants at risk
Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet.
|
MK0249 5 mg
n=10 participants at risk
MK0249 was provided as 1 mg and 5 mg tablets.
|
MK0249 8 mg
n=25 participants at risk
MK0249 was provided as 1 mg and 5 mg tablets.
|
MK0249 10 mg
n=46 participants at risk
MK0249 was provided as 1 mg and 5 mg tablets.
|
MK0249 12 mg
n=39 participants at risk
MK0249 was provided as 1 mg and 5 mg tablets.
|
Modafinil
n=111 participants at risk
Modafinil was provided as 100 mg tablets.
|
|---|---|---|---|---|---|---|
|
General disorders
Increased thirst
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.90%
1/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
4.0%
1/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.6%
1/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.6%
1/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Ear and labyrinth disorders
Ear buzzing
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.6%
1/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Eye disorders
Scleral haemorrhage
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.90%
1/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Eye disorders
Subconjunctival ecchymosis
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.2%
1/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Gastrointestinal disorders
Burping
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.2%
1/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.7%
2/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.6%
1/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
1.8%
2/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
8.0%
2/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.6%
1/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.90%
1/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.6%
1/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Gastrointestinal disorders
Gastric pain
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.90%
1/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Gastrointestinal disorders
Malodorous burping
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.2%
1/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
4.3%
2/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.6%
1/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
1.8%
2/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Gastrointestinal disorders
Stomach ache
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.6%
1/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Gastrointestinal disorders
Stomach fullness
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
10.0%
1/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.2%
1/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.90%
1/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Gastrointestinal disorders
Upset stomach
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.6%
1/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.2%
1/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.7%
3/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
General disorders
Application site rash
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.90%
1/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
General disorders
Chest pain
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.2%
1/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
General disorders
Chest pressure
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
4.0%
1/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
General disorders
Chest tightness
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.2%
1/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.90%
1/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
General disorders
Chills
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.2%
1/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
General disorders
Fever
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.90%
1/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
General disorders
Foot oedema
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.90%
1/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
General disorders
Hand swelling
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.90%
1/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
General disorders
Hangover
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.6%
1/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
General disorders
Implant site pain
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
General disorders
Irritability
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.2%
1/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.6%
1/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
1.8%
2/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
General disorders
Malaise
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.2%
1/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Hepatobiliary disorders
Liver fatty
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Immune system disorders
Seasonal allergy
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Infections and infestations
Cold
|
1.7%
2/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
10.0%
1/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.90%
1/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Infections and infestations
Cold sores
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.90%
1/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Infections and infestations
Cold symptoms
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
4.3%
2/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Infections and infestations
Diverticulitis
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Infections and infestations
Head cold
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.6%
1/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.90%
1/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Infections and infestations
Infection
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.90%
1/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Infections and infestations
Pinkeye
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.90%
1/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Infections and infestations
Sinus infection
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.6%
1/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.7%
2/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.2%
1/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.90%
1/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.90%
1/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Infections and infestations
Yeast infection
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Injury, poisoning and procedural complications
Back strain
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.90%
1/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion of upper arm
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.2%
1/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Injury, poisoning and procedural complications
Device induced injury
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Injury, poisoning and procedural complications
Laceration of foot
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.6%
1/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Injury, poisoning and procedural complications
Lateral epicondylitis
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.90%
1/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Injury, poisoning and procedural complications
Leg injury
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.90%
1/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
10.0%
1/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Injury, poisoning and procedural complications
Pulled muscle
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.90%
1/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Injury, poisoning and procedural complications
Shoulder sprain
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.90%
1/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Investigations
Blood pressure increased
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Investigations
Blood sugar increased
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
4.0%
1/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Investigations
Creatine phosphokinase increased
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
10.0%
1/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
4.0%
1/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.6%
1/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
1.8%
2/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Investigations
Glucose increased
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.90%
1/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Investigations
Glucose urine increased
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.90%
1/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Investigations
Heart rate increased
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.6%
1/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Investigations
Urine calcium oxalate crystal present
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Appetite lost
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
4.0%
1/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back ache
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.6%
1/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
1.7%
2/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Leg cramps
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.2%
1/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Low back pain
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.90%
1/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle ache
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.90%
1/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.6%
1/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
4.0%
1/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.2%
1/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in leg
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Sore back
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Upper back pain
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
10.0%
1/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Nervous system disorders
Attention concentration difficulty
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Nervous system disorders
Concentration impaired
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.6%
1/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.90%
1/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.6%
1/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Nervous system disorders
Head pressure
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.90%
1/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Nervous system disorders
Headache
|
6.0%
7/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
10.0%
1/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
4.3%
2/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
10.3%
4/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
10.8%
12/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Nervous system disorders
Headache dull
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
4.0%
1/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Nervous system disorders
Hypnagogic myoclonus
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
4.0%
1/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Nervous system disorders
Lightheadedness
|
1.7%
2/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.2%
1/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.6%
1/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.90%
1/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Nervous system disorders
Nocturnal headache
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.6%
1/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.6%
1/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Nervous system disorders
Sinus pressure
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.2%
1/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.6%
1/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Nervous system disorders
Taste metallic
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.6%
1/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Nervous system disorders
Tingling feet/hands
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
4.0%
1/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Nervous system disorders
Tremor
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
10.0%
1/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
12.0%
3/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
6.5%
3/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
7.7%
3/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.90%
1/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Psychiatric disorders
Bad dreams
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Psychiatric disorders
Confusion
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Psychiatric disorders
Dreaming excessive
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Psychiatric disorders
Dysphoria
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.6%
1/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Psychiatric disorders
Hallucination, auditory
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.6%
1/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Psychiatric disorders
Initial insomnia
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.2%
1/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
5.1%
2/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.90%
1/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
12.0%
3/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
15.2%
7/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
28.2%
11/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
1.8%
2/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Psychiatric disorders
Middle insomnia
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.2%
1/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Psychiatric disorders
Mood change
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.2%
1/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
5.1%
2/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
1.8%
2/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Psychiatric disorders
Nocturnal awakening
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
4.0%
1/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.2%
1/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.6%
1/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.6%
1/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
5.1%
2/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Psychiatric disorders
Sleep maintenance insomnia
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Psychiatric disorders
Sleep talking
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
10.0%
1/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Psychiatric disorders
Stress
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.90%
1/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Psychiatric disorders
Teeth clenching
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.6%
1/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Psychiatric disorders
Vivid dreams
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
4.0%
1/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.6%
1/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Renal and urinary disorders
Kidney stone
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Renal and urinary disorders
Urinary frequency
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Reproductive system and breast disorders
Ejaculation delayed
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.6%
1/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic sinusitis
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Breath shortness
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.90%
1/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
4.0%
1/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.6%
1/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dry cough
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.90%
1/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal sinus congestion
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.6%
1/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal sinus discharge
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.6%
1/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal stuffiness
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.6%
1/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.6%
1/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Clamminess
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
10.0%
1/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Diaphoresis
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.6%
1/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hives
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.90%
1/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Ingrown toe nail
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Localised erythema
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.90%
1/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
4.3%
2/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
5.1%
2/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.90%
1/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Vascular disorders
Feeling of hot flushes
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Vascular disorders
Generalised flushing
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
2.6%
1/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Vascular disorders
Haematoma
|
0.85%
1/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
|
Vascular disorders
Hot flush
|
0.00%
0/117 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/10 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
4.0%
1/25 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/46 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/39 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
0.00%
0/111 • Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.
Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER