Trial Outcomes & Findings for Safety Trial of Naproxen Sodium/ Diphenhydramine (NCT NCT01365052)
NCT ID: NCT01365052
Last Updated: 2015-06-08
Results Overview
Please see further details in Adverse Events (AE) section
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
326 participants
Primary outcome timeframe
10 days after randomization
Results posted on
2015-06-08
Participant Flow
Participant milestones
| Measure |
Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)
2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
|
Placebo
2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
|
|---|---|---|
|
Overall Study
STARTED
|
217
|
109
|
|
Overall Study
COMPLETED
|
213
|
105
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)
2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
|
Placebo
2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
4
|
Baseline Characteristics
Safety Trial of Naproxen Sodium/ Diphenhydramine
Baseline characteristics by cohort
| Measure |
Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)
n=217 Participants
2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
|
Placebo
n=109 Participants
2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
|
Total
n=326 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.9 years
STANDARD_DEVIATION 18.14 • n=5 Participants
|
47.1 years
STANDARD_DEVIATION 19.26 • n=7 Participants
|
47.0 years
STANDARD_DEVIATION 18.49 • n=5 Participants
|
|
Age, Customized
<60 years
|
152 Participants
70.0 • n=5 Participants
|
72 Participants
66.1 • n=7 Participants
|
224 Participants
n=5 Participants
|
|
Age, Customized
Greater than or equal to 60 years
|
65 Participants
30.0 • n=5 Participants
|
37 Participants
33.9 • n=7 Participants
|
102 Participants
n=5 Participants
|
|
Age, Customized
>65 years
|
46 Participants
21.2 • n=5 Participants
|
28 Participants
25.7 • n=7 Participants
|
74 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
133 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
198 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
84 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 days after randomizationPopulation: Safety population
Please see further details in Adverse Events (AE) section
Outcome measures
| Measure |
Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)
n=217 Participants
2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
|
Placebo
n=109 Participants
2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
|
|---|---|---|
|
Percentage of Subjects With Any Adverse Event for Those Subjects Who Were Randomized and Took at Least One Dose of Investigational Product
|
39.6 Percentage of participants
|
45.0 Percentage of participants
|
PRIMARY outcome
Timeframe: 10 days after randomizationPopulation: Safety population
Please see further details in AE section
Outcome measures
| Measure |
Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)
n=217 Participants
2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
|
Placebo
n=109 Participants
2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
|
|---|---|---|
|
Percentage of Subjects With Any Serious Adverse Event for Those Subjects Who Were Randomized and Took at Least One Dose of Investigational Product
|
0 Percentage of participants
|
0 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 10 days after randomizationPopulation: Safety population
Outcome measures
| Measure |
Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)
n=217 Participants
2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
|
Placebo
n=109 Participants
2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
|
|---|---|---|
|
Percentage of Subjects Who Discontinued Due to an Adverse Event for Those Subjects Who Are Randomized and Take at Least One Dose of Investigational Product
|
1.8 Percentage of participants
|
3.7 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 10 days after randomizationPopulation: Safety population
Outcome measures
| Measure |
Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)
n=217 Participants
2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
|
Placebo
n=109 Participants
2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
|
|---|---|---|
|
Treatment Compliance - Number of Capsules Taken
|
20.1 Capsules
Standard Deviation 1.73
|
19.9 Capsules
Standard Deviation 2.98
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 10 days after randomizationPopulation: Safety population
Outcome measures
| Measure |
Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)
n=217 Participants
2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
|
Placebo
n=109 Participants
2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
|
|---|---|---|
|
Treatment Compliance - Duration of Exposure to Treatment in Days
|
9.9 Days
Standard Deviation 0.76
|
9.8 Days
Standard Deviation 1.37
|
Adverse Events
Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)
Serious events: 0 serious events
Other events: 86 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)
n=217 participants at risk
2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
|
Placebo
n=109 participants at risk
2 over-encapsulated tablets of placebo are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
|
|---|---|---|
|
Blood and lymphatic system disorders
ANISOCYTOSIS
|
0.00%
0/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.92%
1/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Blood and lymphatic system disorders
HYPOCHROMASIA
|
0.00%
0/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.92%
1/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Blood and lymphatic system disorders
MICROCYTOSIS
|
0.00%
0/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.92%
1/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.00%
0/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.92%
1/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Eye disorders
EYE SWELLING
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Eye disorders
VISION BLURRED
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
2.3%
5/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
1.8%
2/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
1.4%
3/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
2.8%
3/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.92%
1/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Gastrointestinal disorders
DIARRHOEA
|
3.2%
7/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
1.8%
2/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Gastrointestinal disorders
DRY MOUTH
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.92%
1/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Gastrointestinal disorders
DYSPEPSIA
|
2.3%
5/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.92%
1/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Gastrointestinal disorders
FAECES DISCOLOURED
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Gastrointestinal disorders
FLATULENCE
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Gastrointestinal disorders
FREQUENT BOWEL MOVEMENTS
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Gastrointestinal disorders
NAUSEA
|
4.1%
9/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.92%
1/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Gastrointestinal disorders
OESOPHAGEAL DISCOMFORT
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Gastrointestinal disorders
OESOPHAGEAL OEDEMA
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Gastrointestinal disorders
OESOPHAGEAL PAIN
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Gastrointestinal disorders
TOOTH LOSS
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Gastrointestinal disorders
TOOTHACHE
|
1.4%
3/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
1.8%
2/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Gastrointestinal disorders
VOMITING
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
General disorders
ASTHENIA
|
0.92%
2/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.92%
1/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
General disorders
EARLY SATIETY
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
General disorders
FATIGUE
|
0.92%
2/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
General disorders
OEDEMA PERIPHERAL
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
General disorders
PAIN
|
0.92%
2/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.92%
1/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
General disorders
PYREXIA
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
General disorders
SWELLING
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
General disorders
THIRST
|
0.92%
2/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Immune system disorders
SEASONAL ALLERGY
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.00%
0/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.92%
1/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Infections and infestations
PHARYNGITIS STREPTOCOCCAL
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Infections and infestations
RHINITIS
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.92%
2/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.92%
1/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Infections and infestations
VULVOVAGINAL MYCOTIC INFECTION
|
0.00%
0/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.92%
1/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Injury, poisoning and procedural complications
EXCORIATION
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Injury, poisoning and procedural complications
LACERATION
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Injury, poisoning and procedural complications
MUSCLE STRAIN
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.92%
1/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Investigations
ALANINE AMINOTRANSFERASE ABNORMAL
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Investigations
BASOPHIL COUNT INCREASED
|
0.00%
0/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.92%
1/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Investigations
BLOOD GLUCOSE INCREASED
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Investigations
BLOOD POTASSIUM INCREASED
|
0.92%
2/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Investigations
BLOOD UREA INCREASED
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Investigations
BLOOD URINE PRESENT
|
0.92%
2/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.92%
1/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Investigations
HAEMATOCRIT DECREASED
|
0.00%
0/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.92%
1/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Investigations
HAEMOGLOBIN DECREASED
|
0.00%
0/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.92%
1/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Investigations
HEART RATE INCREASED
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Investigations
LYMPHOCYTE COUNT INCREASED
|
0.00%
0/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.92%
1/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Investigations
NEUTROPHIL COUNT INCREASED
|
0.00%
0/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.92%
1/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Investigations
RED BLOOD CELL COUNT INCREASED
|
0.00%
0/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.92%
1/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Investigations
RED BLOOD CELLS URINE
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Investigations
URINARY SEDIMENT PRESENT
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
1.8%
2/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Investigations
WEIGHT INCREASED
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Investigations
WHITE BLOOD CELL COUNT INCREASED
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.92%
1/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Investigations
WHITE BLOOD CELLS URINE
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Metabolism and nutrition disorders
FLUID RETENTION
|
0.00%
0/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.92%
1/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Metabolism and nutrition disorders
GOUT
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.92%
1/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.92%
2/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.92%
1/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Metabolism and nutrition disorders
TYPE 2 DIABETES MELLITUS
|
0.00%
0/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.92%
1/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.92%
1/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
3.7%
8/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
2.8%
3/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.00%
0/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.92%
1/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Musculoskeletal and connective tissue disorders
MUSCLE TIGHTNESS
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.92%
1/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL STIFFNESS
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.92%
2/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.92%
2/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
3.7%
4/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Nervous system disorders
DIZZINESS
|
4.1%
9/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Nervous system disorders
DYSGEUSIA
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Nervous system disorders
HEADACHE
|
10.6%
23/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
19.3%
21/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.92%
1/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Nervous system disorders
LETHARGY
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.92%
1/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Nervous system disorders
PSYCHOMOTOR HYPERACTIVITY
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Nervous system disorders
RESTLESS LEGS SYNDROME
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Nervous system disorders
SINUS HEADACHE
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Nervous system disorders
SOMNOLENCE
|
4.6%
10/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
3.7%
4/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Psychiatric disorders
ANXIETY
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Psychiatric disorders
DEPRESSION
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Psychiatric disorders
INSOMNIA
|
1.4%
3/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.92%
1/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Psychiatric disorders
RESTLESSNESS
|
1.4%
3/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.92%
1/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Renal and urinary disorders
GLYCOSURIA
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Renal and urinary disorders
HAEMATURIA
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.92%
1/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Renal and urinary disorders
PYURIA
|
0.00%
0/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.92%
1/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Reproductive system and breast disorders
DYSMENORRHOEA
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Respiratory, thoracic and mediastinal disorders
DRY THROAT
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
0.00%
0/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.92%
1/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.92%
1/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
0.92%
2/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
1.8%
4/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
2.8%
3/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Respiratory, thoracic and mediastinal disorders
RHONCHI
|
0.00%
0/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.92%
1/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Respiratory, thoracic and mediastinal disorders
SINUS CONGESTION
|
0.92%
2/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Respiratory, thoracic and mediastinal disorders
SNEEZING
|
1.4%
3/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Respiratory, thoracic and mediastinal disorders
UPPER-AIRWAY COUGH SYNDROME
|
0.00%
0/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.92%
1/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.46%
1/217 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
0.00%
0/109 • Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60