Trial Outcomes & Findings for Study to Assess Enobosarm (GTx-024) in Postmenopausal Women With Stress Urinary Incontinence (NCT NCT03241342)
NCT ID: NCT03241342
Last Updated: 2021-03-24
Results Overview
Mean number of subject-reported stress incontinence episodes per day through a responder analysis, where a responder is defined as having a ≥ 50% reduction at the end of treatment (Week 12) compared to baseline in the number of stress incontinence episodes
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
491 participants
Primary outcome timeframe
12 Weeks
Results posted on
2021-03-24
Participant Flow
Participant milestones
| Measure |
1 mg GTx-024
Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.
GTx 024: Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024.
|
3 mg GTx-024
Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.
GTx 024: Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024.
|
Matching Placebo
Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.
Placebo: Placebo study drug is identical in appearance to the GTx-024 study drug and contains polyethylene glycol 400 but not GTx-024.
|
|---|---|---|---|
|
Overall Study
STARTED
|
163
|
163
|
165
|
|
Overall Study
COMPLETED
|
141
|
132
|
138
|
|
Overall Study
NOT COMPLETED
|
22
|
31
|
27
|
Reasons for withdrawal
| Measure |
1 mg GTx-024
Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.
GTx 024: Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024.
|
3 mg GTx-024
Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.
GTx 024: Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024.
|
Matching Placebo
Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.
Placebo: Placebo study drug is identical in appearance to the GTx-024 study drug and contains polyethylene glycol 400 but not GTx-024.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
8
|
4
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
1
|
|
Overall Study
noncompliance with study drug
|
2
|
1
|
1
|
|
Overall Study
sponsor decision
|
0
|
1
|
2
|
|
Overall Study
not reported
|
15
|
21
|
19
|
Baseline Characteristics
Study to Assess Enobosarm (GTx-024) in Postmenopausal Women With Stress Urinary Incontinence
Baseline characteristics by cohort
| Measure |
1 mg GTx-024
n=163 Participants
Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.
GTx 024: Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024.
|
3 mg GTx-024
n=163 Participants
Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.
GTx 024: Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024.
|
Matching Placebo
n=165 Participants
Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.
Placebo: Placebo study drug is identical in appearance to the GTx-024 study drug and contains polyethylene glycol 400 but not GTx-024.
|
Total
n=491 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
149 Participants
n=5 Participants
|
152 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
451 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Age, Continuous
|
60 years
n=5 Participants
|
59 years
n=7 Participants
|
58 years
n=5 Participants
|
59 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
163 Participants
n=5 Participants
|
163 Participants
n=7 Participants
|
165 Participants
n=5 Participants
|
491 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
25 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
131 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
420 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Baseline number of stress incontinence episodes per day
|
4.588 episodes per day
n=5 Participants
|
4.329 episodes per day
n=7 Participants
|
4.459 episodes per day
n=5 Participants
|
4.4 episodes per day
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 WeeksPopulation: full analysis set
Mean number of subject-reported stress incontinence episodes per day through a responder analysis, where a responder is defined as having a ≥ 50% reduction at the end of treatment (Week 12) compared to baseline in the number of stress incontinence episodes
Outcome measures
| Measure |
1 mg GTx-024
n=163 Participants
Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.
GTx 024: Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024.
|
3 mg GTx-024
n=163 Participants
Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.
GTx 024: Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024.
|
Matching Placebo
n=165 Participants
Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.
Placebo: Placebo study drug is identical in appearance to the GTx-024 study drug and contains polyethylene glycol 400 but not GTx-024.
|
|---|---|---|---|
|
Number of Participants With a ≥ 50% Reduction From Baseline in the Mean Number of Stress Incontinence Episodes Per Day at Week 12
|
94 Participants
|
96 Participants
|
87 Participants
|
Adverse Events
1 mg GTx-024
Serious events: 3 serious events
Other events: 105 other events
Deaths: 0 deaths
3 mg GTx-024
Serious events: 2 serious events
Other events: 104 other events
Deaths: 0 deaths
Matching Placebo
Serious events: 4 serious events
Other events: 96 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1 mg GTx-024
n=163 participants at risk
Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.
GTx 024: Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024.
|
3 mg GTx-024
n=163 participants at risk
Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.
GTx 024: Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024.
|
Matching Placebo
n=165 participants at risk
Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.
Placebo: Placebo study drug is identical in appearance to the GTx-024 study drug and contains polyethylene glycol 400 but not GTx-024.
|
|---|---|---|---|
|
Cardiac disorders
acute myocardial infarction
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Endocrine disorders
goiter
|
0.00%
0/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Infections and infestations
abscessed limb
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Infections and infestations
osteomyelitis
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Injury, poisoning and procedural complications
hip fracture
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Musculoskeletal and connective tissue disorders
spinal disorder
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Nervous system disorders
cerebral vascular accident
|
0.00%
0/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary congestion
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Nervous system disorders
dysaesthesia
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
Other adverse events
| Measure |
1 mg GTx-024
n=163 participants at risk
Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.
GTx 024: Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024.
|
3 mg GTx-024
n=163 participants at risk
Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.
GTx 024: Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024.
|
Matching Placebo
n=165 participants at risk
Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.
Placebo: Placebo study drug is identical in appearance to the GTx-024 study drug and contains polyethylene glycol 400 but not GTx-024.
|
|---|---|---|---|
|
Infections and infestations
post procedural infection
|
0.00%
0/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Infections and infestations
respiratory tract infection viral
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Infections and infestations
rhinitis
|
0.00%
0/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Infections and infestations
sinusitis
|
0.00%
0/163 • 7 months
|
1.2%
2/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Infections and infestations
streptococcal infection
|
0.00%
0/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Infections and infestations
tooth infection
|
0.61%
1/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Blood and lymphatic system disorders
anemia
|
0.00%
0/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Blood and lymphatic system disorders
lymphadenopathy
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Blood and lymphatic system disorders
polycythaemia
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Blood and lymphatic system disorders
thrombocytosis
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Cardiac disorders
acute myocardial infarction
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Cardiac disorders
cardiomegaly
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Cardiac disorders
palpitations
|
0.61%
1/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Ear and labyrinth disorders
ear discomfort
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Ear and labyrinth disorders
motion sickness
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Ear and labyrinth disorders
vertigo
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Endocrine disorders
goiter
|
0.00%
0/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Endocrine disorders
hypothyroidism
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Eye disorders
blepharitis
|
0.61%
1/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Eye disorders
chalazion
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Eye disorders
dry eye
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Eye disorders
eye discharge
|
0.00%
0/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Eye disorders
eye pain
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Eye disorders
eye swelling
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Eye disorders
vision blurred
|
1.2%
2/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Eye disorders
visual impairment
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Gastrointestinal disorders
abdominal discomfort
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Gastrointestinal disorders
abdominal distension
|
1.2%
2/163 • 7 months
|
0.00%
0/163 • 7 months
|
1.2%
2/165 • 7 months
|
|
Gastrointestinal disorders
abdominal hernia
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Gastrointestinal disorders
abdominal pain
|
1.2%
2/163 • 7 months
|
0.61%
1/163 • 7 months
|
1.2%
2/165 • 7 months
|
|
Gastrointestinal disorders
abdominal pain lower
|
0.00%
0/163 • 7 months
|
0.61%
1/163 • 7 months
|
1.2%
2/165 • 7 months
|
|
Gastrointestinal disorders
abdominal pain upper
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Gastrointestinal disorders
change of bowel habit
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Gastrointestinal disorders
colitis
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Gastrointestinal disorders
constipation
|
2.5%
4/163 • 7 months
|
1.8%
3/163 • 7 months
|
1.8%
3/165 • 7 months
|
|
Gastrointestinal disorders
diarrhea
|
1.2%
2/163 • 7 months
|
1.8%
3/163 • 7 months
|
3.0%
5/165 • 7 months
|
|
Gastrointestinal disorders
diverticulum
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Gastrointestinal disorders
dry mouth
|
0.61%
1/163 • 7 months
|
3.1%
5/163 • 7 months
|
2.4%
4/165 • 7 months
|
|
Gastrointestinal disorders
dyspepsia
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Gastrointestinal disorders
eructation
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Gastrointestinal disorders
flatulence
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
1.2%
2/165 • 7 months
|
|
Gastrointestinal disorders
food poisoning
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Gastrointestinal disorders
gastritis
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Gastrointestinal disorders
hemorrhoids
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Gastrointestinal disorders
nausea
|
2.5%
4/163 • 7 months
|
2.5%
4/163 • 7 months
|
4.2%
7/165 • 7 months
|
|
Gastrointestinal disorders
oesophageal stenosis
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Gastrointestinal disorders
vomiting
|
1.2%
2/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
General disorders
chest pain
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
General disorders
cyst
|
0.00%
0/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
General disorders
energy increased
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
General disorders
fatigue
|
1.2%
2/163 • 7 months
|
1.8%
3/163 • 7 months
|
1.8%
3/165 • 7 months
|
|
General disorders
feeling abnormal
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
General disorders
feeling hot
|
0.00%
0/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
General disorders
hypothermia
|
0.00%
0/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
General disorders
influenza like illness
|
0.61%
1/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
General disorders
malaise
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
General disorders
non cardiac chest pain
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
General disorders
oedema peripheral
|
4.3%
7/163 • 7 months
|
1.8%
3/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
General disorders
peripheral swelling
|
0.61%
1/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
General disorders
polyp
|
0.00%
0/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
General disorders
pyrexia
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
General disorders
thirst
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Immune system disorders
hypersensitivity
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Infections and infestations
abscess limb
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Infections and infestations
acute sinusitis
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Infections and infestations
bronchitis
|
1.8%
3/163 • 7 months
|
1.8%
3/163 • 7 months
|
1.8%
3/165 • 7 months
|
|
Infections and infestations
candida infection
|
0.00%
0/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Infections and infestations
cellulitis
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Infections and infestations
clostridium difficile infection
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Infections and infestations
diverticulitis
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Infections and infestations
ear infection
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Infections and infestations
escherichia
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Infections and infestations
eye infection
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Infections and infestations
fungal infection
|
0.61%
1/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Infections and infestations
gastroenteritis
|
0.00%
0/163 • 7 months
|
1.2%
2/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Infections and infestations
gastroenteritis viral
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
1.2%
2/165 • 7 months
|
|
Infections and infestations
genital herpes
|
0.00%
0/163 • 7 months
|
1.8%
3/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Infections and infestations
herpes zoster
|
1.8%
3/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Infections and infestations
influenza
|
1.8%
3/163 • 7 months
|
1.8%
3/163 • 7 months
|
1.8%
3/165 • 7 months
|
|
Infections and infestations
localized infection
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Infections and infestations
mycoplasma infection
|
0.00%
0/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Infections and infestations
nasopharyngitis
|
2.5%
4/163 • 7 months
|
4.3%
7/163 • 7 months
|
3.6%
6/165 • 7 months
|
|
Infections and infestations
osteomyelitis
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Infections and infestations
otitis media acute
|
0.00%
0/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Infections and infestations
pharyngitis
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Infections and infestations
pneumonia
|
0.61%
1/163 • 7 months
|
0.61%
1/163 • 7 months
|
1.8%
3/165 • 7 months
|
|
Infections and infestations
upper respiratory tract infection
|
4.3%
7/163 • 7 months
|
4.3%
7/163 • 7 months
|
6.1%
10/165 • 7 months
|
|
Infections and infestations
urinary tract infection
|
10.4%
17/163 • 7 months
|
17.8%
29/163 • 7 months
|
10.9%
18/165 • 7 months
|
|
Infections and infestations
urinary tract infection fungal
|
0.00%
0/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Infections and infestations
vaginal infection
|
0.61%
1/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Infections and infestations
viral infection
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Infections and infestations
vulvovaginal mycotic infection
|
1.2%
2/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Injury, poisoning and procedural complications
arthropod bite
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Injury, poisoning and procedural complications
contusion
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Injury, poisoning and procedural complications
fall
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Injury, poisoning and procedural complications
foot fracture
|
0.00%
0/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Injury, poisoning and procedural complications
hip fracture
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Injury, poisoning and procedural complications
joint injury
|
0.00%
0/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Injury, poisoning and procedural complications
laceration
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Injury, poisoning and procedural complications
ligament rupture
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Injury, poisoning and procedural complications
ligament sprain
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Injury, poisoning and procedural complications
post procedural haematoma
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Injury, poisoning and procedural complications
procedural pain
|
0.00%
0/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Injury, poisoning and procedural complications
radius fracture
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Injury, poisoning and procedural complications
rib fracture
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Injury, poisoning and procedural complications
soft tissue injury
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Injury, poisoning and procedural complications
sternal fracture
|
0.00%
0/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Injury, poisoning and procedural complications
tendon rupture
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Injury, poisoning and procedural complications
tibia fracture
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Injury, poisoning and procedural complications
tooth fracture
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Investigations
alanine aminotransferase increasae
|
0.61%
1/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Investigations
aspartate aminotransferase increase
|
0.61%
1/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Investigations
blood alkaline phosphatase increase
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Investigations
blood creatinine phophokinase mb increase
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Investigations
blood creatinine phosphokinase increase
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Investigations
blood creatinine decrease
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Investigations
blood creatinine increase
|
4.3%
7/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Investigations
blood glucose increase
|
1.2%
2/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Investigations
blood pressure increase
|
0.00%
0/163 • 7 months
|
0.61%
1/163 • 7 months
|
1.2%
2/165 • 7 months
|
|
Investigations
blood urine present
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Investigations
c reactive protein increase
|
0.61%
1/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
1.8%
3/163 • 7 months
|
1.8%
3/163 • 7 months
|
1.8%
3/165 • 7 months
|
|
Musculoskeletal and connective tissue disorders
back pain
|
1.8%
3/163 • 7 months
|
1.2%
2/163 • 7 months
|
1.2%
2/165 • 7 months
|
|
Musculoskeletal and connective tissue disorders
fibromyalgia
|
0.61%
1/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Musculoskeletal and connective tissue disorders
intervertebral disc protrusion
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
1.2%
2/165 • 7 months
|
|
Musculoskeletal and connective tissue disorders
limb discomfort
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
1.2%
2/165 • 7 months
|
|
Musculoskeletal and connective tissue disorders
muscle spasms
|
1.2%
2/163 • 7 months
|
1.8%
3/163 • 7 months
|
2.4%
4/165 • 7 months
|
|
Musculoskeletal and connective tissue disorders
muscle weakness
|
0.00%
0/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal chest pain
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal pain
|
0.61%
1/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
1.8%
3/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Musculoskeletal and connective tissue disorders
neck pain
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
2.5%
4/163 • 7 months
|
1.8%
3/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Musculoskeletal and connective tissue disorders
poly arthritis
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Musculoskeletal and connective tissue disorders
rotator cuff syndrome
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
1.2%
2/165 • 7 months
|
|
Musculoskeletal and connective tissue disorders
spinal disorder
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Musculoskeletal and connective tissue disorders
systemic lupus erythematosus
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Musculoskeletal and connective tissue disorders
tendonitis
|
0.61%
1/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
gastrointestinal tract adenoma
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
laryngeal papilloma
|
0.00%
0/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Nervous system disorders
burning sensation
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Nervous system disorders
cerebrovascular accident
|
0.00%
0/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Nervous system disorders
dizziness
|
2.5%
4/163 • 7 months
|
0.61%
1/163 • 7 months
|
1.2%
2/165 • 7 months
|
|
Nervous system disorders
dysaesthesia
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Nervous system disorders
dysarthria
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Nervous system disorders
headache
|
1.8%
3/163 • 7 months
|
7.4%
12/163 • 7 months
|
4.2%
7/165 • 7 months
|
|
Nervous system disorders
memory impairment
|
0.00%
0/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Nervous system disorders
migraine
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Nervous system disorders
neuropathy peripheral
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Nervous system disorders
paraesthesia
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Nervous system disorders
sciatica
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Nervous system disorders
somnolence
|
0.61%
1/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Nervous system disorders
tension headache
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Psychiatric disorders
affect lability
|
0.00%
0/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Psychiatric disorders
agitation
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
1.2%
2/165 • 7 months
|
|
Psychiatric disorders
anger
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Psychiatric disorders
anxiety
|
0.00%
0/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Psychiatric disorders
attention deficit hyperactivity disorder
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Psychiatric disorders
bruxism
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Psychiatric disorders
confusional state
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Psychiatric disorders
depression
|
0.61%
1/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Psychiatric disorders
emotional disorder
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Psychiatric disorders
insomnia
|
0.00%
0/163 • 7 months
|
3.1%
5/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Psychiatric disorders
irritability
|
0.00%
0/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Psychiatric disorders
libido increase
|
0.00%
0/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Psychiatric disorders
mental disorder
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Psychiatric disorders
sleep disorder
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Renal and urinary disorders
azotemia
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Renal and urinary disorders
bladder disorder
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Renal and urinary disorders
bladder pain
|
0.00%
0/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Renal and urinary disorders
contracted bladder
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Renal and urinary disorders
dysuria
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Renal and urinary disorders
hematuria
|
1.8%
3/163 • 7 months
|
1.2%
2/163 • 7 months
|
1.8%
3/165 • 7 months
|
|
Renal and urinary disorders
leukocyturia
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Renal and urinary disorders
micturition urgency
|
0.00%
0/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Renal and urinary disorders
nephrolithiasis
|
1.2%
2/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Renal and urinary disorders
nocturia
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Renal and urinary disorders
polyuria
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Renal and urinary disorders
stress urinary incontinence
|
0.00%
0/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Renal and urinary disorders
urethral caruncle
|
0.00%
0/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Renal and urinary disorders
urinary incontinence
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Renal and urinary disorders
urinary retention
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Renal and urinary disorders
urine odor abnormal
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Reproductive system and breast disorders
breast cyst
|
0.00%
0/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Reproductive system and breast disorders
breast tenderness
|
1.2%
2/163 • 7 months
|
1.2%
2/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Reproductive system and breast disorders
clitoral engorgement
|
0.00%
0/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Reproductive system and breast disorders
coital bleeding
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Reproductive system and breast disorders
cystocele
|
0.00%
0/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Reproductive system and breast disorders
endometrial thickening
|
1.2%
2/163 • 7 months
|
0.61%
1/163 • 7 months
|
1.8%
3/165 • 7 months
|
|
Reproductive system and breast disorders
hydrometra
|
1.8%
3/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Reproductive system and breast disorders
ovarian cyst
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Reproductive system and breast disorders
pelvic congestion
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Reproductive system and breast disorders
pelvic pain
|
0.61%
1/163 • 7 months
|
0.61%
1/163 • 7 months
|
1.2%
2/165 • 7 months
|
|
Reproductive system and breast disorders
uterine polyp
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Reproductive system and breast disorders
vaginal discharge
|
1.2%
2/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Reproductive system and breast disorders
vaginal enlargement
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Reproductive system and breast disorders
vaginal hemorrhage
|
0.61%
1/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Reproductive system and breast disorders
vaginal lesion
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Reproductive system and breast disorders
vulva cyst
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Reproductive system and breast disorders
vulvovaginal discomfort
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Reproductive system and breast disorders
vulvovaginal pruritus
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Respiratory, thoracic and mediastinal disorders
asthma
|
0.61%
1/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Respiratory, thoracic and mediastinal disorders
chronic obstructive pulmonary disease
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
1.8%
3/163 • 7 months
|
1.2%
2/163 • 7 months
|
1.2%
2/165 • 7 months
|
|
Respiratory, thoracic and mediastinal disorders
dysphonia
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
1.2%
2/163 • 7 months
|
1.2%
2/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Respiratory, thoracic and mediastinal disorders
oropharyngeal pain
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Respiratory, thoracic and mediastinal disorders
productive cough
|
0.00%
0/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary congestion
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary mass
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Respiratory, thoracic and mediastinal disorders
reflux laryngitis
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Respiratory, thoracic and mediastinal disorders
respiratory tract congestion
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Respiratory, thoracic and mediastinal disorders
sinus congestion
|
0.00%
0/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Respiratory, thoracic and mediastinal disorders
sleep apnea syndrome
|
0.00%
0/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Respiratory, thoracic and mediastinal disorders
throat irritation
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Respiratory, thoracic and mediastinal disorders
upper airway cough syndrome
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Respiratory, thoracic and mediastinal disorders
wheezing
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Skin and subcutaneous tissue disorders
acne
|
0.61%
1/163 • 7 months
|
1.8%
3/163 • 7 months
|
1.8%
3/165 • 7 months
|
|
Skin and subcutaneous tissue disorders
alopecia
|
1.2%
2/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Skin and subcutaneous tissue disorders
dermatitis
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Skin and subcutaneous tissue disorders
dermatitis atopic
|
0.00%
0/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Skin and subcutaneous tissue disorders
dry skin
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Skin and subcutaneous tissue disorders
ecchymosis
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Skin and subcutaneous tissue disorders
eczema
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Skin and subcutaneous tissue disorders
hirsutism
|
0.00%
0/163 • 7 months
|
0.61%
1/163 • 7 months
|
1.8%
3/165 • 7 months
|
|
Skin and subcutaneous tissue disorders
hyperhidrosis
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
1.2%
2/165 • 7 months
|
|
Skin and subcutaneous tissue disorders
photosensitivity reaction
|
0.00%
0/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Skin and subcutaneous tissue disorders
pruritus
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Skin and subcutaneous tissue disorders
rash
|
1.2%
2/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Skin and subcutaneous tissue disorders
rash papular
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Skin and subcutaneous tissue disorders
rosacea
|
0.00%
0/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Skin and subcutaneous tissue disorders
seborrhoea
|
1.2%
2/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Skin and subcutaneous tissue disorders
skin exfoliation
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Skin and subcutaneous tissue disorders
skin irritation
|
0.00%
0/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Respiratory, thoracic and mediastinal disorders
urticaria
|
0.61%
1/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Vascular disorders
aortic aneurysm
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
|
Vascular disorders
flushing
|
0.00%
0/163 • 7 months
|
0.61%
1/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Vascular disorders
hot flush
|
0.61%
1/163 • 7 months
|
2.5%
4/163 • 7 months
|
0.00%
0/165 • 7 months
|
|
Vascular disorders
hypertension
|
1.8%
3/163 • 7 months
|
3.7%
6/163 • 7 months
|
1.2%
2/165 • 7 months
|
|
Vascular disorders
hypertensive crisis
|
0.00%
0/163 • 7 months
|
0.00%
0/163 • 7 months
|
0.61%
1/165 • 7 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place