Trial Outcomes & Findings for A Study in Men With Low Testosterone to Measure the Effects of Testosterone Solution on Testosterone Levels, Sex Drive and Energy (NCT NCT01816295)
NCT ID: NCT01816295
Last Updated: 2015-12-28
Results Overview
Normal range for total serum testosterone was defined as 300 to 1050 nanograms per deciliter (ng/dL).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
715 participants
Primary outcome timeframe
Week 12
Results posted on
2015-12-28
Participant Flow
Participant milestones
| Measure |
Placebo Solution
Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 - 120 mg/day) for 24 weeks.
|
Testosterone Solution
Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 - 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 - 120 mg/day) for 24 weeks.
|
|---|---|---|
|
Double Blind Phase
STARTED
|
357
|
358
|
|
Double Blind Phase
Received Study Drug
|
356
|
354
|
|
Double Blind Phase
COMPLETED
|
294
|
302
|
|
Double Blind Phase
NOT COMPLETED
|
63
|
56
|
|
OLE Phase
STARTED
|
275
|
283
|
|
OLE Phase
COMPLETED
|
222
|
227
|
|
OLE Phase
NOT COMPLETED
|
53
|
56
|
Reasons for withdrawal
| Measure |
Placebo Solution
Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 - 120 mg/day) for 24 weeks.
|
Testosterone Solution
Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 - 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 - 120 mg/day) for 24 weeks.
|
|---|---|---|
|
Double Blind Phase
Adverse Event
|
11
|
8
|
|
Double Blind Phase
Entry Criteria Not Met
|
0
|
2
|
|
Double Blind Phase
Lost to Follow-up
|
3
|
5
|
|
Double Blind Phase
Physician Decision
|
2
|
2
|
|
Double Blind Phase
Protocol Violation
|
17
|
11
|
|
Double Blind Phase
Sponsor Decision
|
8
|
8
|
|
Double Blind Phase
Withdrawal by Subject
|
22
|
20
|
|
OLE Phase
Adverse Event
|
17
|
15
|
|
OLE Phase
Death
|
1
|
0
|
|
OLE Phase
Entry Criteria Not Met
|
3
|
5
|
|
OLE Phase
Lost to Follow-up
|
5
|
5
|
|
OLE Phase
Physician Decision
|
3
|
1
|
|
OLE Phase
Protocol Violation
|
4
|
4
|
|
OLE Phase
Sponsor Decision
|
7
|
9
|
|
OLE Phase
Withdrawal by Subject
|
10
|
10
|
|
OLE Phase
Lack of Efficacy
|
3
|
7
|
Baseline Characteristics
A Study in Men With Low Testosterone to Measure the Effects of Testosterone Solution on Testosterone Levels, Sex Drive and Energy
Baseline characteristics by cohort
| Measure |
Placebo Solution
n=357 Participants
Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 - 120 mg/day) for 24 weeks.
|
Testosterone Solution
n=358 Participants
Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 - 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 - 120 mg/day) for 24 weeks.
|
Total
n=715 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.9 years
STANDARD_DEVIATION 11.35 • n=5 Participants
|
54.7 years
STANDARD_DEVIATION 10.58 • n=7 Participants
|
55.3 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
|
357 Participants
n=5 Participants
|
358 Participants
n=7 Participants
|
715 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
51 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
280 Participants
n=5 Participants
|
279 Participants
n=7 Participants
|
559 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
26 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
38 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
26 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
282 Participants
n=5 Participants
|
281 Participants
n=7 Participants
|
563 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 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
East Asia
|
34 participants
n=5 Participants
|
40 participants
n=7 Participants
|
74 participants
n=5 Participants
|
|
Region of Enrollment
Europe
|
63 participants
n=5 Participants
|
57 participants
n=7 Participants
|
120 participants
n=5 Participants
|
|
Region of Enrollment
South America
|
28 participants
n=5 Participants
|
30 participants
n=7 Participants
|
58 participants
n=5 Participants
|
|
Region of Enrollment
North America
|
232 participants
n=5 Participants
|
231 participants
n=7 Participants
|
463 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
30.9 kilogram per square meter (kg/m²)
STANDARD_DEVIATION 4.21 • n=5 Participants
|
30.3 kilogram per square meter (kg/m²)
STANDARD_DEVIATION 4.06 • n=7 Participants
|
30.6 kilogram per square meter (kg/m²)
STANDARD_DEVIATION 4.14 • n=5 Participants
|
|
Symptoms of Hypogonadism
Only Low Energy
|
49 participants
n=5 Participants
|
47 participants
n=7 Participants
|
96 participants
n=5 Participants
|
|
Symptoms of Hypogonadism
Only Decreased Sexual Drive
|
39 participants
n=5 Participants
|
40 participants
n=7 Participants
|
79 participants
n=5 Participants
|
|
Symptoms of Hypogonadism
Both Symptoms Present
|
269 participants
n=5 Participants
|
271 participants
n=7 Participants
|
540 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: All randomized participants who completed 12 weeks of treatment and had non-missing testosterone concentration at week 12.
Normal range for total serum testosterone was defined as 300 to 1050 nanograms per deciliter (ng/dL).
Outcome measures
| Measure |
Placebo Solution
n=287 Participants
Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 - 120 mg/day) for 24 weeks.
|
Testosterone Solution
n=297 Participants
Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 - 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 - 120 mg/day) for 24 weeks.
|
|---|---|---|
|
Number of Participants With Total Serum Testosterone Concentration Within Normal Range at Week 12
|
43 participants
|
217 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Randomized participants who reported low sex drive at baseline with non-missing SAID Scale data at baseline and at least one post baseline visit. Missing data endpoints were imputed using last observation carried forward (LOCF).
The SAID Scale is a self-administered instrument used to assess sexual arousal, interest, and sex drive in men with symptomatic hypogonadism. The SAID consists of 5 questions that were scored on a scale from 1 to 5, with "5" corresponding to greater levels of sexual arousal, interest, or drive. The SAID Scale total score was computed by summing the item scores and linearly transforming the sum to a 0 to 100 scale, with higher scores corresponding to greater sexual arousal, interest, and drive. Least squares (LS) mean change from baseline was calculated using an analysis of covariance (ANCOVA) with treatment group and the baseline value as covariates.
Outcome measures
| Measure |
Placebo Solution
n=257 Participants
Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 - 120 mg/day) for 24 weeks.
|
Testosterone Solution
n=244 Participants
Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 - 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 - 120 mg/day) for 24 weeks.
|
|---|---|---|
|
Change From Baseline to Week 12 in Sexual Arousal, Interest, and Drive (SAID) Scale Scores
|
6.3 units on a scale
Standard Error 0.99
|
11.4 units on a scale
Standard Error 1.02
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Randomized participants who reported low energy at baseline with non-missing HED questionnaire at baseline and at least one post baseline visit. Missing data endpoints were imputed using LOCF.
The HED is a self-administered instrument used to assess real-time energy levels in men with symptomatic hypogonadism. It consists of 2 questions that were scored on a scale from 0 to 10, with "10" corresponding to "Full of Energy" or "Not Tired at All" (The Tiredness scale was reverse-mapped, as it was collected with "10" corresponding to "Extreme Tiredness"). The questionnaire was completed 3 times daily (forming 6 unique items) for 7 consecutive days. Item scores were computed by averaging the values for each item across 7 days. If more than 2 days were missing for an item, the item score was missing. The total score was computed by summing the item scores and linearly transforming the sum to a 0 to 100 scale, with higher scores corresponding to greater energy. If any item score was missing, the total score was missing. LS mean change from baseline was calculated using ANCOVA with treatment group and the baseline value as covariates.
Outcome measures
| Measure |
Placebo Solution
n=243 Participants
Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 - 120 mg/day) for 24 weeks.
|
Testosterone Solution
n=230 Participants
Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 - 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 - 120 mg/day) for 24 weeks.
|
|---|---|---|
|
Change From Baseline to Week 12 in Hypogonadism Energy Diary (HED) Scores
|
7.5 units on a scale
Standard Error 0.87
|
10.5 units on a scale
Standard Error 0.89
|
SECONDARY outcome
Timeframe: Double Blind Baseline, Week 12, Open Label Baseline, Week 36Population: All participants with non-missing PSA result at the specified time point.
Outcome measures
| Measure |
Placebo Solution
n=350 Participants
Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 - 120 mg/day) for 24 weeks.
|
Testosterone Solution
n=347 Participants
Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 - 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 - 120 mg/day) for 24 weeks.
|
|---|---|---|
|
Number of Participants With Prostate Specific Antigen (PSA) >4 Nanogram/Milliliter (ng/mL)
Double-Blind Baseline (n=350, 347)
|
1 participants
|
0 participants
|
|
Number of Participants With Prostate Specific Antigen (PSA) >4 Nanogram/Milliliter (ng/mL)
Week 12 (n=289, 299)
|
3 participants
|
4 participants
|
|
Number of Participants With Prostate Specific Antigen (PSA) >4 Nanogram/Milliliter (ng/mL)
Open Label Baseline (n=269, 278)
|
0 participants
|
0 participants
|
|
Number of Participants With Prostate Specific Antigen (PSA) >4 Nanogram/Milliliter (ng/mL)
Week 36 (n=219, 223)
|
4 participants
|
4 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 12, Week 36Population: All randomized participants with non-missing baseline IPSS measurement and at least one non-missing post baseline IPSS measurement. Missing data endpoints were imputed using LOCF.
The IPSS is a self-administered instrument used to assess for the severity of lower urinary tract symptoms. The IPSS consists of 7 questions that were scored on a scale from 0 (none/no symptoms) to 5 (frequent symptoms), for a total score range of 0 to 35. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. LS mean change from baseline was calculated using ANCOVA with treatment group and the baseline value as covariates.
Outcome measures
| Measure |
Placebo Solution
n=320 Participants
Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 - 120 mg/day) for 24 weeks.
|
Testosterone Solution
n=324 Participants
Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 - 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 - 120 mg/day) for 24 weeks.
|
|---|---|---|
|
Change From Baseline in Total International Prostate Symptom Score (IPSS)
Change from Baseline to Week 12
|
-0.7 units on a scale
Standard Error 0.24
|
-0.9 units on a scale
Standard Error 0.24
|
|
Change From Baseline in Total International Prostate Symptom Score (IPSS)
Change from Baseline to Week 36 (n=247, 255)
|
-0.7 units on a scale
Standard Error 0.28
|
-0.7 units on a scale
Standard Error 0.27
|
Adverse Events
Placebo Solution - Double Blind
Serious events: 8 serious events
Other events: 143 other events
Deaths: 0 deaths
Testosterone Solution - Double Blind
Serious events: 4 serious events
Other events: 148 other events
Deaths: 0 deaths
Testosterone Solution - OLE
Serious events: 24 serious events
Other events: 252 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Solution - Double Blind
n=356 participants at risk
Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period.
|
Testosterone Solution - Double Blind
n=354 participants at risk
Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 - 120 mg/day) for 12 week double-blind treatment period.
|
Testosterone Solution - OLE
n=558 participants at risk
Sixty mg testosterone solution applied topically to axillae once daily at 60 mg/day with possible down/up titration (30 - 120 mg/day) for 24 weeks in optional OLE period.
|
|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Cardiac disorders
Angina unstable
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Bacterial disease carrier
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Endocarditis enterococcal
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Influenza
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Septic embolus
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Brachial plexus injury
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Foreign body
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Haematuria traumatic
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lentigo maligna
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage iv
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Nervous system disorders
Ischaemic stroke
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Nervous system disorders
Seizure
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.36%
2/558 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Vascular disorders
Venous thrombosis limb
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
Other adverse events
| Measure |
Placebo Solution - Double Blind
n=356 participants at risk
Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period.
|
Testosterone Solution - Double Blind
n=354 participants at risk
Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 - 120 mg/day) for 12 week double-blind treatment period.
|
Testosterone Solution - OLE
n=558 participants at risk
Sixty mg testosterone solution applied topically to axillae once daily at 60 mg/day with possible down/up titration (30 - 120 mg/day) for 24 weeks in optional OLE period.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Cardiac disorders
Palpitations
|
0.56%
2/356 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Cardiac disorders
Sinus bradycardia
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.36%
2/558 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.36%
2/558 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.36%
2/558 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Eye disorders
Blepharospasm
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Eye disorders
Dry eye
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.1%
4/356 • Number of events 4
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.90%
5/558 • Number of events 5
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.56%
2/354 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.56%
2/354 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gingival cyst
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.56%
2/354 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.36%
2/558 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Intestinal mass
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.36%
2/558 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.56%
2/354 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Rectal fissure
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Salivary duct obstruction
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.72%
4/558 • Number of events 4
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
General disorders
Application site acne
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
General disorders
Application site dryness
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
General disorders
Application site eczema
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
General disorders
Application site erythema
|
0.84%
3/356 • Number of events 3
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.72%
4/558 • Number of events 4
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
General disorders
Application site irritation
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.56%
2/354 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.54%
3/558 • Number of events 3
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
General disorders
Application site pain
|
2.0%
7/356 • Number of events 7
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
1.7%
6/354 • Number of events 6
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.36%
2/558 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
General disorders
Application site pruritus
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
General disorders
Application site rash
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.72%
4/558 • Number of events 4
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
General disorders
Application site reaction
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
General disorders
Application site warmth
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
General disorders
Axillary pain
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.56%
2/354 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
General disorders
Chills
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
General disorders
Cyst
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
General disorders
Cyst rupture
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
General disorders
Effusion
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
1.1%
4/354 • Number of events 4
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.36%
2/558 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
General disorders
Haemorrhagic cyst
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
General disorders
Influenza like illness
|
0.56%
2/356 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.36%
2/558 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
General disorders
Local swelling
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.54%
3/558 • Number of events 3
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
General disorders
Oedema
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.85%
3/354 • Number of events 3
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.54%
3/558 • Number of events 3
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
General disorders
Peripheral swelling
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.56%
2/354 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
General disorders
Therapeutic response unexpected
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Immune system disorders
Allergy to arthropod sting
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Immune system disorders
Drug hypersensitivity
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Immune system disorders
Multiple allergies
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Abscess limb
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Acute sinusitis
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Application site pustules
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.36%
2/558 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Bronchitis
|
0.84%
3/356 • Number of events 4
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
1.3%
7/558 • Number of events 7
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Candida infection
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.54%
3/558 • Number of events 3
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Chest wall abscess
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Conjunctivitis
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.36%
2/558 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Ear infection
|
1.7%
6/356 • Number of events 6
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Erythema induratum
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Folliculitis
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.36%
2/558 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Fungal infection
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.36%
2/558 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Furuncle
|
0.56%
2/356 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.84%
3/356 • Number of events 3
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.56%
2/354 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.90%
5/558 • Number of events 5
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Herpes zoster
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Influenza
|
0.84%
3/356 • Number of events 3
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.85%
3/354 • Number of events 3
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
1.8%
10/558 • Number of events 10
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Localised infection
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Nasal vestibulitis
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
3.1%
11/356 • Number of events 11
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
2.3%
8/354 • Number of events 8
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
3.4%
19/558 • Number of events 21
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Ophthalmic herpes zoster
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Paronychia
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Pharyngitis
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.56%
2/354 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.54%
3/558 • Number of events 3
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.72%
4/558 • Number of events 4
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Rhinitis
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Sinusitis
|
0.56%
2/356 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.85%
3/354 • Number of events 3
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.90%
5/558 • Number of events 6
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Tinea cruris
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.36%
2/558 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Tinea pedis
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Tooth abscess
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.36%
2/558 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.7%
6/356 • Number of events 6
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
2.3%
8/354 • Number of events 9
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
3.4%
19/558 • Number of events 20
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Urethritis
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.56%
2/354 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.54%
3/558 • Number of events 3
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.36%
2/558 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.36%
2/558 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.36%
2/558 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Human bite
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.36%
2/558 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.56%
2/354 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.54%
3/558 • Number of events 3
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.36%
2/558 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.36%
2/558 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Investigations
Blood creatine phosphokinase abnormal
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Investigations
Blood creatinine increased
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Investigations
Blood follicle stimulating hormone increased
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Investigations
Blood glucose decreased
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Investigations
Blood glucose increased
|
0.84%
3/356 • Number of events 3
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Investigations
Blood insulin increased
|
0.56%
2/356 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Investigations
Blood luteinising hormone increased
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Investigations
Blood pressure increased
|
0.56%
2/356 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.36%
2/558 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Investigations
Blood testosterone increased
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.54%
3/558 • Number of events 3
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Investigations
Blood triglycerides increased
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Investigations
Blood urea increased
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.56%
2/354 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Investigations
Electrocardiogram p wave abnormal
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Investigations
Electrocardiogram repolarisation abnormality
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.56%
2/356 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Investigations
Glycosylated haemoglobin increased
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Investigations
Haematocrit increased
|
0.56%
2/356 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
2.5%
9/354 • Number of events 9
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
5.0%
28/558 • Number of events 28
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Investigations
Haemoglobin increased
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Investigations
Hepatic enzyme increased
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Investigations
High density lipoprotein increased
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.54%
3/558 • Number of events 3
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Investigations
Lymph node palpable
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Investigations
Mean cell volume increased
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Investigations
Prostatic specific antigen
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Investigations
Prostatic specific antigen abnormal
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Investigations
Prostatic specific antigen increased
|
0.56%
2/356 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
1.1%
4/354 • Number of events 4
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
1.1%
6/558 • Number of events 6
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Investigations
Red blood cell count decreased
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Investigations
Red blood cell count increased
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Investigations
Weight decreased
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.56%
2/354 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Investigations
Weight increased
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.56%
2/356 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Gout
|
0.28%
1/356 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.72%
4/558 • Number of events 5
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.84%
3/356 • Number of events 3
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.85%
3/354 • Number of events 3
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.56%
2/354 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.36%
2/558 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.36%
2/558 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.36%
2/558 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.54%
3/558 • Number of events 3
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.56%
2/356 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Vitamin b complex deficiency
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Vitamin d deficiency
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.36%
2/558 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.1%
4/356 • Number of events 4
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
2.3%
8/354 • Number of events 8
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
1.1%
6/558 • Number of events 7
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Axillary mass
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.4%
5/356 • Number of events 5
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
1.4%
5/354 • Number of events 5
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
2.9%
16/558 • Number of events 16
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.56%
2/354 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.36%
2/558 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.54%
3/558 • Number of events 3
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.36%
2/558 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.56%
2/354 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.36%
2/558 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.56%
2/354 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.36%
2/558 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acoustic neuroma
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
|
0.56%
2/356 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected neoplasm
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm prostate
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Nervous system disorders
Burning sensation
|
1.1%
4/356 • Number of events 5
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
1.7%
6/354 • Number of events 7
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.36%
2/558 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
1.1%
4/356 • Number of events 4
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.72%
4/558 • Number of events 4
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
2.2%
8/356 • Number of events 8
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.85%
3/354 • Number of events 3
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
1.3%
7/558 • Number of events 7
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.56%
2/354 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Nervous system disorders
Mental impairment
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.56%
2/354 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Nervous system disorders
Paralysis
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Nervous system disorders
Sensory disturbance
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Nervous system disorders
Sleep phase rhythm disturbance
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.54%
3/558 • Number of events 3
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Nervous system disorders
Trigeminal nerve disorder
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Nervous system disorders
Writer's cramp
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Psychiatric disorders
Aggression
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Psychiatric disorders
Agitation
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Psychiatric disorders
Anger
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.54%
3/558 • Number of events 4
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.56%
2/356 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.56%
2/354 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
1.1%
6/558 • Number of events 6
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.56%
2/354 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.54%
3/558 • Number of events 3
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Psychiatric disorders
Drug dependence
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Psychiatric disorders
Eating disorder
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.56%
2/356 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.85%
3/354 • Number of events 3
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.54%
3/558 • Number of events 3
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.36%
2/558 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Psychiatric disorders
Libido increased
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Psychiatric disorders
Loss of libido
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Psychiatric disorders
Middle insomnia
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Psychiatric disorders
Personality disorder
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Psychiatric disorders
Premature ejaculation
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.36%
2/558 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Psychiatric disorders
Restlessness
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Psychiatric disorders
Sleep disorder
|
0.84%
3/356 • Number of events 3
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Renal and urinary disorders
Calculus urinary
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.36%
2/558 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.36%
2/558 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Renal and urinary disorders
Lower urinary tract symptoms
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Renal and urinary disorders
Micturition disorder
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.36%
2/558 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Renal and urinary disorders
Pollakiuria
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.54%
3/558 • Number of events 3
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Renal and urinary disorders
Polyuria
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Breast mass
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.54%
3/558 • Number of events 3
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Genital paraesthesia
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Nipple disorder
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Nipple pain
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.85%
3/354 • Number of events 3
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Painful erection
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.56%
2/356 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Pruritus genital
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Spermatic cord pain
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Testicular atrophy
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Testicular swelling
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.56%
2/356 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
1.1%
4/354 • Number of events 4
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
1.3%
7/558 • Number of events 7
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.1%
4/356 • Number of events 4
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.54%
3/558 • Number of events 3
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.54%
3/558 • Number of events 3
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.72%
4/558 • Number of events 5
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.36%
2/558 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.84%
3/356 • Number of events 3
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.56%
2/354 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
1.8%
10/558 • Number of events 11
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.56%
2/356 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.56%
2/354 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.36%
2/558 • Number of events 3
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.56%
2/354 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.36%
2/558 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
1.1%
4/354 • Number of events 4
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hair growth abnormal
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.36%
2/558 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.1%
4/356 • Number of events 4
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.85%
3/354 • Number of events 3
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.54%
3/558 • Number of events 3
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.8%
10/356 • Number of events 11
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
1.1%
4/354 • Number of events 4
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.36%
2/558 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.56%
2/354 • Number of events 3
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
2.5%
9/356 • Number of events 9
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
1.1%
4/354 • Number of events 5
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Social circumstances
Alcohol use
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Social circumstances
Sexual activity increased
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Social circumstances
Substance use
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Surgical and medical procedures
Arthrodesis
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Surgical and medical procedures
Corneal transplant
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Surgical and medical procedures
Endodontic procedure
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Surgical and medical procedures
High frequency ablation
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Surgical and medical procedures
Inguinal hernia repair
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Surgical and medical procedures
Knee operation
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Surgical and medical procedures
Meniscus operation
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.36%
2/558 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Surgical and medical procedures
Orthodontic procedure
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Surgical and medical procedures
Posterior lens capsulotomy
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Surgical and medical procedures
Rotator cuff repair
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Surgical and medical procedures
Suture insertion
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Surgical and medical procedures
Umbilical hernia repair
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.36%
2/558 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Surgical and medical procedures
Vasectomy
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Surgical and medical procedures
Vitrectomy
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Surgical and medical procedures
Wisdom teeth removal
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Vascular disorders
Flushing
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.56%
2/354 • Number of events 2
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Vascular disorders
Hot flush
|
0.28%
1/356 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
1.1%
4/356 • Number of events 4
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
1.1%
4/354 • Number of events 4
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.72%
4/558 • Number of events 4
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.28%
1/354 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/558
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/356
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.00%
0/354
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
0.18%
1/558 • Number of events 1
Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60