Trial Outcomes & Findings for A Study of Tadalafil (LY450190) in Chinese Men With Erectile Dysfunction (NCT NCT02224846)
NCT ID: NCT02224846
Last Updated: 2019-09-23
Results Overview
A Treatment Emergent Adverse Event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline, regardless of causality or severity. The percentage of participants with TEAEs was calculated by dividing the number of participants with at least 1 TEAE over the 12-Month treatment period by the total number of participants analyzed, multiplied by 100%. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
635 participants
Primary outcome timeframe
Baseline through Month 12
Results posted on
2019-09-23
Participant Flow
Participant milestones
| Measure |
2.5 mg/5 mg Tadalafil
2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2).
|
5 mg Tadalafil
5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).
|
|---|---|---|
|
Period 1 (Month 3)
STARTED
|
211
|
424
|
|
Period 1 (Month 3)
Received at Least One Dose of Study Drug
|
210
|
421
|
|
Period 1 (Month 3)
COMPLETED
|
192
|
388
|
|
Period 1 (Month 3)
NOT COMPLETED
|
19
|
36
|
|
Period 2 (Month 3 to Month 12)
STARTED
|
192
|
388
|
|
Period 2 (Month 3 to Month 12)
COMPLETED
|
173
|
357
|
|
Period 2 (Month 3 to Month 12)
NOT COMPLETED
|
19
|
31
|
|
Period 2 (Month 12 to Month 24)
STARTED
|
173
|
357
|
|
Period 2 (Month 12 to Month 24)
COMPLETED
|
131
|
283
|
|
Period 2 (Month 12 to Month 24)
NOT COMPLETED
|
42
|
74
|
Reasons for withdrawal
| Measure |
2.5 mg/5 mg Tadalafil
2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2).
|
5 mg Tadalafil
5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).
|
|---|---|---|
|
Period 1 (Month 3)
Adverse Event
|
2
|
1
|
|
Period 1 (Month 3)
Lost to Follow-up
|
3
|
8
|
|
Period 1 (Month 3)
Protocol Violation
|
4
|
8
|
|
Period 1 (Month 3)
Withdrawal by Subject
|
8
|
18
|
|
Period 1 (Month 3)
Sponsor Decision
|
2
|
1
|
|
Period 2 (Month 3 to Month 12)
Adverse Event
|
1
|
2
|
|
Period 2 (Month 3 to Month 12)
Lost to Follow-up
|
3
|
5
|
|
Period 2 (Month 3 to Month 12)
Protocol Violation
|
0
|
3
|
|
Period 2 (Month 3 to Month 12)
Withdrawal by Subject
|
15
|
19
|
|
Period 2 (Month 3 to Month 12)
Physician Decision
|
0
|
2
|
|
Period 2 (Month 12 to Month 24)
Adverse Event
|
3
|
4
|
|
Period 2 (Month 12 to Month 24)
Death
|
1
|
0
|
|
Period 2 (Month 12 to Month 24)
Lost to Follow-up
|
7
|
13
|
|
Period 2 (Month 12 to Month 24)
Protocol Violation
|
4
|
11
|
|
Period 2 (Month 12 to Month 24)
Withdrawal by Subject
|
25
|
43
|
|
Period 2 (Month 12 to Month 24)
Physician Decision
|
0
|
2
|
|
Period 2 (Month 12 to Month 24)
Sponsor Decision
|
2
|
1
|
Baseline Characteristics
A Study of Tadalafil (LY450190) in Chinese Men With Erectile Dysfunction
Baseline characteristics by cohort
| Measure |
2.5 mg/5 mg Tadalafil
n=211 Participants
2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2).
|
5 mg Tadalafil
n=424 Participants
5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).
|
Total
n=635 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.6 years
STANDARD_DEVIATION 11.11 • n=5 Participants
|
44.1 years
STANDARD_DEVIATION 10.90 • n=7 Participants
|
43.6 years
STANDARD_DEVIATION 10.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
211 Participants
n=5 Participants
|
424 Participants
n=7 Participants
|
635 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
211 Participants
n=5 Participants
|
424 Participants
n=7 Participants
|
635 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
211 Participants
n=5 Participants
|
424 Participants
n=7 Participants
|
635 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through Month 12Population: All enrolled participants who fulfill the study entry criteria and who receive at least one dose of tadalafil.
A Treatment Emergent Adverse Event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline, regardless of causality or severity. The percentage of participants with TEAEs was calculated by dividing the number of participants with at least 1 TEAE over the 12-Month treatment period by the total number of participants analyzed, multiplied by 100%. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Outcome measures
| Measure |
2.5 mg/5 mg Tadalafil
n=210 Participants
2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2).
|
5 mg Tadalafil
n=421 Participants
5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).
|
|---|---|---|
|
Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (Serious or Non-Serious)
|
33.8 Percentage of participants
|
35.9 Percentage of participants
|
PRIMARY outcome
Timeframe: Baseline through Month 12Population: All enrolled participants who fulfill the study entry criteria and who receive at least one dose of tadalafil.
Data presented are the number of participants who experienced 1 or more AEs (all causalities and drug-related) and serious AEs (SAEs) that lead to discontinuation. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Outcome measures
| Measure |
2.5 mg/5 mg Tadalafil
n=210 Participants
2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2).
|
5 mg Tadalafil
n=421 Participants
5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).
|
|---|---|---|
|
Percentage of Participants Experiencing at Least One Adverse Event Leading to Discontinuation
|
1.4 percentage of participants
|
0.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Month 1; Baseline, Month 3Population: All enrolled participants who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data.
IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) mean of the change from baseline is from Mixed effect Model Repeat Measurement (MMRM) model. The model included covariates baseline + visit + pooled investigator + baseline\*visit, where participant is a random effect.
Outcome measures
| Measure |
2.5 mg/5 mg Tadalafil
n=203 Participants
2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2).
|
5 mg Tadalafil
n=414 Participants
5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).
|
|---|---|---|
|
Change From Baseline in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain Questionnaire Score
Month 1
|
4.5 units on a scale
Standard Error 0.42
|
6.2 units on a scale
Standard Error 0.28
|
|
Change From Baseline in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain Questionnaire Score
Month 3
|
6.1 units on a scale
Standard Error 0.44
|
7.4 units on a scale
Standard Error 0.28
|
SECONDARY outcome
Timeframe: Baseline, Month 6; Baseline, Month 12;Baseline, Month 18; Baseline, Month 24Population: All enrolled participants who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data.
IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) mean of the change from baseline is from Mixed effect Model Repeat Measurement (MMRM) model. The model included covariates baseline + visit + pooled investigator + baseline\*visit, where participant is a random effect.
Outcome measures
| Measure |
2.5 mg/5 mg Tadalafil
n=203 Participants
2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2).
|
5 mg Tadalafil
n=414 Participants
5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).
|
|---|---|---|
|
Change From Baseline in the IIEF-EF Domain Questionnaire Score of 5 mg Tadalafil Treatments
Month 12
|
8.1 units on a scale
Standard Error 0.43
|
7.9 units on a scale
Standard Error 0.27
|
|
Change From Baseline in the IIEF-EF Domain Questionnaire Score of 5 mg Tadalafil Treatments
Month 18
|
8.6 units on a scale
Standard Error 0.39
|
8.3 units on a scale
Standard Error 0.27
|
|
Change From Baseline in the IIEF-EF Domain Questionnaire Score of 5 mg Tadalafil Treatments
Month 24
|
8.6 units on a scale
Standard Error 0.44
|
8.5 units on a scale
Standard Error 0.28
|
|
Change From Baseline in the IIEF-EF Domain Questionnaire Score of 5 mg Tadalafil Treatments
Month 6
|
8.2 units on a scale
Standard Error 0.38
|
7.9 units on a scale
Standard Error 0.27
|
SECONDARY outcome
Timeframe: Month 1, Month 3Population: All enrolled subjects who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data.
Participant-assessed diary has 5 questions(QI-Q5): 4 of the 5 questions were analyzed. Q2: successful penetration, Q3: successful intercourse, Q4: satisfied with erection, and Q5: satisfied with sexual experience) for each sexual encounter made over a specified period of time. SEP Q1-Q5 scores were determined as the percentage of 'Yes' responses to each of the 5 questions out of all sexual attempts recorded during the time period.
Outcome measures
| Measure |
2.5 mg/5 mg Tadalafil
n=203 Participants
2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2).
|
5 mg Tadalafil
n=412 Participants
5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).
|
|---|---|---|
|
Percentage of Participants With "Yes" Responses to Sexual Encounter Profile (SEP) Diary
Q2: successful penetration,Month 1
|
81.3 Percentage of participants
Standard Deviation 34.58
|
86.7 Percentage of participants
Standard Deviation 27.58
|
|
Percentage of Participants With "Yes" Responses to Sexual Encounter Profile (SEP) Diary
Q3: successful intercourse,Month 1
|
41.2 Percentage of participants
Standard Deviation 41.48
|
49.5 Percentage of participants
Standard Deviation 42.85
|
|
Percentage of Participants With "Yes" Responses to Sexual Encounter Profile (SEP) Diary
Q3: successful intercourse,Month 3
|
55.7 Percentage of participants
Standard Deviation 43.19
|
60.1 Percentage of participants
Standard Deviation 42.39
|
|
Percentage of Participants With "Yes" Responses to Sexual Encounter Profile (SEP) Diary
Q4: satisfied with erection, Month 1
|
24.8 Percentage of participants
Standard Deviation 35.62
|
35.5 Percentage of participants
Standard Deviation 41.63
|
|
Percentage of Participants With "Yes" Responses to Sexual Encounter Profile (SEP) Diary
Q5: satisfied with sexual experience,Month 1
|
20.4 Percentage of participants
Standard Deviation 32.81
|
31.1 Percentage of participants
Standard Deviation 40.50
|
|
Percentage of Participants With "Yes" Responses to Sexual Encounter Profile (SEP) Diary
Q2: successful penetration,Month 3
|
88.2 Percentage of participants
Standard Deviation 28.55
|
91.7 Percentage of participants
Standard Deviation 23.11
|
|
Percentage of Participants With "Yes" Responses to Sexual Encounter Profile (SEP) Diary
Q4: satisfied with erection, Month 3
|
39.9 Percentage of participants
Standard Deviation 43.73
|
43.5 Percentage of participants
Standard Deviation 43.46
|
|
Percentage of Participants With "Yes" Responses to Sexual Encounter Profile (SEP) Diary
Q5: satisfied with sexual experience,Month 3
|
35.7 Percentage of participants
Standard Deviation 41.93
|
39.2 Percentage of participants
Standard Deviation 43.06
|
SECONDARY outcome
Timeframe: Month 1, Month 3Population: All enrolled subjects who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data.
Participants achieving a normal erectile functioning (defined as having an IIEF-EF Domain score of \>=26) at Month 1 and Month 3.
Outcome measures
| Measure |
2.5 mg/5 mg Tadalafil
n=210 Participants
2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2).
|
5 mg Tadalafil
n=421 Participants
5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).
|
|---|---|---|
|
Percentage of Participants Achieving Normal Erectile Functioning
Month 1
|
22.2 Percentage of partcipants
|
30.9 Percentage of partcipants
|
|
Percentage of Participants Achieving Normal Erectile Functioning
Month 3
|
31.6 Percentage of partcipants
|
37.6 Percentage of partcipants
|
SECONDARY outcome
Timeframe: Month 6, Month 12, Month 18, Month 24Population: All enrolled subjects who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data.
Participants achieving a normal erectile functioning (defined as having an IIEF-EF Domain score of \>=26) at Month 6 and Month 12.
Outcome measures
| Measure |
2.5 mg/5 mg Tadalafil
n=210 Participants
2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2).
|
5 mg Tadalafil
n=421 Participants
5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).
|
|---|---|---|
|
Percentage of Participants Achieving Normal Erectile Functioning of 5 mg Tadalafil Treatments
Month 24
|
45.5 Percentage of participants
|
48.2 Percentage of participants
|
|
Percentage of Participants Achieving Normal Erectile Functioning of 5 mg Tadalafil Treatments
Month 6
|
38.2 Percentage of participants
|
42.3 Percentage of participants
|
|
Percentage of Participants Achieving Normal Erectile Functioning of 5 mg Tadalafil Treatments
Month 12
|
44.1 Percentage of participants
|
43.5 Percentage of participants
|
|
Percentage of Participants Achieving Normal Erectile Functioning of 5 mg Tadalafil Treatments
Month 18
|
44.6 Percentage of participants
|
43.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Month 3, Month12, Month 24Population: All randomized participants who had evaluable data for Global Assessment Questions (GAQ)1 and GAQ2.
Participants with "yes" responses to GAQ Question 1 (GAQ1) and GAQ Question 2 (GAQ2) of the GAQ questionnaire at Month 3 and Month 12. GAQ1: Has the treatment you have been taking during this study improved your erections? GAQ2: If yes, has the treatment improved your ability to engage in sexual activity?
Outcome measures
| Measure |
2.5 mg/5 mg Tadalafil
n=211 Participants
2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2).
|
5 mg Tadalafil
n=424 Participants
5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).
|
|---|---|---|
|
Percentage of Participants With "Yes" Responses to Global Assessment Questions (GAQ)1 and GAQ2
Month 3: GAQ1
|
89.6 percentage of participants
|
95.7 percentage of participants
|
|
Percentage of Participants With "Yes" Responses to Global Assessment Questions (GAQ)1 and GAQ2
Month 12: GAQ1
|
96.6 percentage of participants
|
97.5 percentage of participants
|
|
Percentage of Participants With "Yes" Responses to Global Assessment Questions (GAQ)1 and GAQ2
Month 24: GAQ1
|
96.8 percentage of participants
|
95.7 percentage of participants
|
|
Percentage of Participants With "Yes" Responses to Global Assessment Questions (GAQ)1 and GAQ2
Month 12: GAQ2
|
95.5 percentage of participants
|
96.1 percentage of participants
|
|
Percentage of Participants With "Yes" Responses to Global Assessment Questions (GAQ)1 and GAQ2
Month 24: GAQ2
|
96.2 percentage of participants
|
94.5 percentage of participants
|
|
Percentage of Participants With "Yes" Responses to Global Assessment Questions (GAQ)1 and GAQ2
Month 3: GAQ2
|
86.5 percentage of participants
|
92.1 percentage of participants
|
Adverse Events
2.5 mg/5 mg Tadalafil
Serious events: 15 serious events
Other events: 86 other events
Deaths: 0 deaths
5 mg Tadalafil
Serious events: 17 serious events
Other events: 178 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
2.5 mg/5 mg Tadalafil
n=210 participants at risk
2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2).
|
5 mg Tadalafil
n=421 participants at risk
5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).
|
|---|---|---|
|
Cardiac disorders
Angina unstable
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Eye disorders
Maculopathy
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.95%
2/210 • Number of events 2
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Infections and infestations
Otitis media
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Urethral stricture postoperative
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.95%
2/210 • Number of events 2
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cerebral infarction
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal cyst
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.48%
1/210 • Number of events 2
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Varicocele
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
2.5 mg/5 mg Tadalafil
n=210 participants at risk
2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2).
|
5 mg Tadalafil
n=421 participants at risk
5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).
|
|---|---|---|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal mass
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Nervous system disorders
Migraine
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Nervous system disorders
Poor quality sleep
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.48%
2/421 • Number of events 2
All the participants who received at least one dose of study drug.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Agitation
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
1.9%
4/210 • Number of events 4
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Irritability
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Premature ejaculation
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Sleep disorder
|
0.95%
2/210 • Number of events 2
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Calculus urinary
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Glomerulonephritis chronic
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.95%
2/210 • Number of events 4
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal cyst
|
0.95%
2/210 • Number of events 2
All the participants who received at least one dose of study drug.
|
0.48%
2/421 • Number of events 2
All the participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Cardiac disorders
Arrhythmia
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Cardiac disorders
Microvascular coronary artery disease
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Excessive cerumen production
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Mixed deafness
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Endocrine disorders
Thyroid mass
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.48%
2/421 • Number of events 2
All the participants who received at least one dose of study drug.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Eye disorders
Dry eye
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Eye disorders
Eye disorder
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Eye disorders
Eye swelling
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Eye disorders
Uveitis
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Eye disorders
Vision blurred
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.48%
2/421 • Number of events 2
All the participants who received at least one dose of study drug.
|
|
Eye disorders
Xerophthalmia
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 2
All the participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.71%
3/421 • Number of events 3
All the participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.95%
2/210 • Number of events 2
All the participants who received at least one dose of study drug.
|
0.71%
3/421 • Number of events 3
All the participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.95%
2/210 • Number of events 2
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.9%
4/210 • Number of events 6
All the participants who received at least one dose of study drug.
|
0.95%
4/421 • Number of events 4
All the participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Chronic gastritis
|
1.9%
4/210 • Number of events 4
All the participants who received at least one dose of study drug.
|
0.71%
3/421 • Number of events 3
All the participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dental caries
|
1.4%
3/210 • Number of events 4
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
3/210 • Number of events 3
All the participants who received at least one dose of study drug.
|
1.2%
5/421 • Number of events 6
All the participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.48%
2/421 • Number of events 2
All the participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.71%
3/421 • Number of events 3
All the participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Enteritis
|
0.95%
2/210 • Number of events 2
All the participants who received at least one dose of study drug.
|
0.48%
2/421 • Number of events 2
All the participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastric dilatation
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.48%
2/421 • Number of events 2
All the participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.95%
2/210 • Number of events 2
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.48%
2/421 • Number of events 2
All the participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
1.4%
3/210 • Number of events 3
All the participants who received at least one dose of study drug.
|
1.9%
8/421 • Number of events 10
All the participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.71%
3/421 • Number of events 3
All the participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.95%
2/210 • Number of events 2
All the participants who received at least one dose of study drug.
|
0.95%
4/421 • Number of events 5
All the participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gingival swelling
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.71%
3/421 • Number of events 3
All the participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.95%
4/421 • Number of events 4
All the participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.71%
3/421 • Number of events 3
All the participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Tooth disorder
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
1.4%
6/421 • Number of events 6
All the participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
General disorders
Chest discomfort
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
General disorders
Chest pain
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
General disorders
Pain
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
1.4%
3/210 • Number of events 3
All the participants who received at least one dose of study drug.
|
0.95%
4/421 • Number of events 4
All the participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 2
All the participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Fatty liver alcoholic
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.48%
2/421 • Number of events 2
All the participants who received at least one dose of study drug.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Infections and infestations
Anal abscess
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Infections and infestations
Bronchitis
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
1.2%
5/421 • Number of events 6
All the participants who received at least one dose of study drug.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Infections and infestations
Conjunctivitis
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.71%
3/421 • Number of events 3
All the participants who received at least one dose of study drug.
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Infections and infestations
Dermatophytosis
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Infections and infestations
Ear infection
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Infections and infestations
Epididymitis
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.71%
3/421 • Number of events 3
All the participants who received at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.71%
3/421 • Number of events 3
All the participants who received at least one dose of study drug.
|
|
Infections and infestations
Gingivitis
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Infections and infestations
Helicobacter infection
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Infections and infestations
Hepatitis b
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Infections and infestations
Hordeolum
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Infections and infestations
Infected dermal cyst
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Infections and infestations
Influenza
|
0.95%
2/210 • Number of events 2
All the participants who received at least one dose of study drug.
|
0.71%
3/421 • Number of events 4
All the participants who received at least one dose of study drug.
|
|
Infections and infestations
Laryngitis
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Infections and infestations
Lung infection
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Infections and infestations
Mumps
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Infections and infestations
Otitis media
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.95%
4/421 • Number of events 4
All the participants who received at least one dose of study drug.
|
|
Infections and infestations
Otitis media chronic
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 2
All the participants who received at least one dose of study drug.
|
|
Infections and infestations
Periodontitis
|
2.9%
6/210 • Number of events 6
All the participants who received at least one dose of study drug.
|
0.71%
3/421 • Number of events 3
All the participants who received at least one dose of study drug.
|
|
Infections and infestations
Pharyngitis
|
1.4%
3/210 • Number of events 3
All the participants who received at least one dose of study drug.
|
1.9%
8/421 • Number of events 8
All the participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Infections and infestations
Pulpitis dental
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.48%
2/421 • Number of events 2
All the participants who received at least one dose of study drug.
|
|
Infections and infestations
Respiratory tract infection
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.71%
3/421 • Number of events 3
All the participants who received at least one dose of study drug.
|
|
Infections and infestations
Rhinitis
|
1.4%
3/210 • Number of events 3
All the participants who received at least one dose of study drug.
|
1.2%
5/421 • Number of events 6
All the participants who received at least one dose of study drug.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Infections and infestations
Tinea cruris
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Infections and infestations
Tinea infection
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Infections and infestations
Tinea manuum
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 2
All the participants who received at least one dose of study drug.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.71%
3/421 • Number of events 3
All the participants who received at least one dose of study drug.
|
|
Infections and infestations
Tonsillitis
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.4%
5/210 • Number of events 5
All the participants who received at least one dose of study drug.
|
5.0%
21/421 • Number of events 25
All the participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
1.4%
3/210 • Number of events 3
All the participants who received at least one dose of study drug.
|
0.48%
2/421 • Number of events 2
All the participants who received at least one dose of study drug.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
8.6%
18/210 • Number of events 24
All the participants who received at least one dose of study drug.
|
9.3%
39/421 • Number of events 48
All the participants who received at least one dose of study drug.
|
|
Infections and infestations
Wound infection
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Electrical burn
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Foreign body
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.48%
2/421 • Number of events 2
All the participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Heat stroke
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.71%
3/421 • Number of events 3
All the participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.71%
3/421 • Number of events 3
All the participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Peripheral nerve injury
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.48%
2/421 • Number of events 2
All the participants who received at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
2.4%
5/210 • Number of events 5
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Investigations
Blood cholesterol increased
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Investigations
Blood glucose increased
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Investigations
Blood pressure increased
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.71%
3/421 • Number of events 3
All the participants who received at least one dose of study drug.
|
|
Investigations
Blood pressure systolic increased
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Investigations
Blood triglycerides increased
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.48%
2/421 • Number of events 2
All the participants who received at least one dose of study drug.
|
|
Investigations
Blood urea increased
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Investigations
Blood uric acid increased
|
1.9%
4/210 • Number of events 4
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.95%
2/210 • Number of events 2
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Investigations
High density lipoprotein increased
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Investigations
Lipids increased
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Investigations
Low density lipoprotein increased
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Investigations
Platelet count decreased
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Investigations
White blood cell count increased
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Folate deficiency
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Gout
|
0.95%
2/210 • Number of events 2
All the participants who received at least one dose of study drug.
|
0.48%
2/421 • Number of events 2
All the participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.95%
4/421 • Number of events 5
All the participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.48%
2/421 • Number of events 2
All the participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.48%
2/421 • Number of events 2
All the participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.71%
3/421 • Number of events 3
All the participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.48%
2/421 • Number of events 2
All the participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.4%
3/210 • Number of events 3
All the participants who received at least one dose of study drug.
|
0.95%
4/421 • Number of events 5
All the participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.95%
4/421 • Number of events 5
All the participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.48%
2/421 • Number of events 2
All the participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 2
All the participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.48%
2/421 • Number of events 2
All the participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Vertebral lesion
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.71%
3/421 • Number of events 5
All the participants who received at least one dose of study drug.
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cerebral artery stenosis
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
1.4%
3/210 • Number of events 3
All the participants who received at least one dose of study drug.
|
2.1%
9/421 • Number of events 9
All the participants who received at least one dose of study drug.
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
0.95%
2/210 • Number of events 2
All the participants who received at least one dose of study drug.
|
3.1%
13/421 • Number of events 14
All the participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Urethral pain
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Urinary retention
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.71%
3/421 • Number of events 3
All the participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Epididymal cyst
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Prostatitis
|
3.3%
7/210 • Number of events 7
All the participants who received at least one dose of study drug.
|
0.95%
4/421 • Number of events 4
All the participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.95%
2/210 • Number of events 2
All the participants who received at least one dose of study drug.
|
1.2%
5/421 • Number of events 5
All the participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.95%
2/210 • Number of events 2
All the participants who received at least one dose of study drug.
|
0.48%
2/421 • Number of events 2
All the participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal inflammation
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.71%
3/421 • Number of events 3
All the participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Reflux laryngitis
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.4%
3/210 • Number of events 3
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.71%
3/421 • Number of events 3
All the participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.48%
2/421 • Number of events 2
All the participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.4%
3/210 • Number of events 3
All the participants who received at least one dose of study drug.
|
0.48%
2/421 • Number of events 2
All the participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.48%
2/421 • Number of events 2
All the participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.48%
2/421 • Number of events 2
All the participants who received at least one dose of study drug.
|
|
Social circumstances
Breast feeding
|
0.00%
0/210
All the participants who received at least one dose of study drug.
|
0.24%
1/421 • Number of events 1
All the participants who received at least one dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
|
Vascular disorders
Flushing
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.48%
2/421 • Number of events 2
All the participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
1.4%
3/210 • Number of events 3
All the participants who received at least one dose of study drug.
|
1.9%
8/421 • Number of events 9
All the participants who received at least one dose of study drug.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.48%
1/210 • Number of events 1
All the participants who received at least one dose of study drug.
|
0.00%
0/421
All the participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60