Trial Outcomes & Findings for Assessment Study of Steroid Effect in Relapsing Multiple Sclerosis Subjects Treated With Glatiramer Acetate (NCT NCT00203047)
NCT ID: NCT00203047
Last Updated: 2014-01-06
Results Overview
Results represent the database as of January 29, 2009. Brain volume was measured at baseline and at months 24, 36 and at early termination visits by magnetic resonance imaging (MRI). Brain atrophy was measured by comparing the change in brain volume from baseline to the latest scan at the three during study timeframes. SIENA is a fully automated method of analyzing longitudinal brain change. Adjusted (least square) mean values are presented.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
414 participants
Primary outcome timeframe
Day 0, latest scan at month 24, 36 or early termination visit
Results posted on
2014-01-06
Participant Flow
Participant milestones
| Measure |
GA + Placebo
Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily.
|
GA + Prednisone
Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.
|
|---|---|---|
|
Overall Study
STARTED
|
204
|
210
|
|
Overall Study
In Database as of January 29, 2009
|
199
|
209
|
|
Overall Study
COMPLETED
|
13
|
7
|
|
Overall Study
NOT COMPLETED
|
191
|
203
|
Reasons for withdrawal
| Measure |
GA + Placebo
Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily.
|
GA + Prednisone
Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.
|
|---|---|---|
|
Overall Study
Ongoing: in database - January 29, 2009
|
131
|
109
|
|
Overall Study
Ongoing: not in database - Jan 29, 2009
|
5
|
1
|
|
Overall Study
Withdrawal by Subject
|
13
|
47
|
|
Overall Study
Teva requested participant withdrawal
|
1
|
1
|
|
Overall Study
Physician Decision
|
8
|
7
|
|
Overall Study
Non-compliance
|
4
|
8
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
11
|
5
|
|
Overall Study
Adverse Event
|
8
|
18
|
|
Overall Study
Death
|
1
|
2
|
|
Overall Study
Pregnancy
|
3
|
0
|
|
Overall Study
Other
|
5
|
5
|
Baseline Characteristics
Assessment Study of Steroid Effect in Relapsing Multiple Sclerosis Subjects Treated With Glatiramer Acetate
Baseline characteristics by cohort
| Measure |
GA + Placebo
n=199 Participants
Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily.
|
GA + Prednisone
n=209 Participants
Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.
|
Total
n=408 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<=29 years
|
32 participants
n=5 Participants
|
40 participants
n=7 Participants
|
72 participants
n=5 Participants
|
|
Age, Customized
=30 and < 40 years
|
61 participants
n=5 Participants
|
68 participants
n=7 Participants
|
129 participants
n=5 Participants
|
|
Age, Customized
=40 and < 50 years
|
70 participants
n=5 Participants
|
70 participants
n=7 Participants
|
140 participants
n=5 Participants
|
|
Age, Customized
=50 and < 55 years
|
35 participants
n=5 Participants
|
29 participants
n=7 Participants
|
64 participants
n=5 Participants
|
|
Age, Customized
>= 55 years
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
151 Participants
n=5 Participants
|
157 Participants
n=7 Participants
|
308 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian / Oriental
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black of African Heritage
|
13 participants
n=5 Participants
|
15 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
171 participants
n=5 Participants
|
179 participants
n=7 Participants
|
350 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
16 participants
n=5 Participants
|
20 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
179 participants
n=5 Participants
|
188 participants
n=7 Participants
|
367 participants
n=5 Participants
|
|
Time from First Multiple Sclerosis (MS) Symptom
|
89.8 months
STANDARD_DEVIATION 104.5 • n=5 Participants
|
76.7 months
STANDARD_DEVIATION 75.5 • n=7 Participants
|
83.1 months
STANDARD_DEVIATION 91.0 • n=5 Participants
|
|
Time from MS Diagnosis
|
40.5 months
STANDARD_DEVIATION 71.4 • n=5 Participants
|
42.1 months
STANDARD_DEVIATION 62.9 • n=7 Participants
|
41.3 months
STANDARD_DEVIATION 67.1 • n=5 Participants
|
|
T1 Enhancing Lesions at Baseline
|
1.05 lesions
STANDARD_DEVIATION 2.77 • n=5 Participants
|
1.86 lesions
STANDARD_DEVIATION 9.91 • n=7 Participants
|
1.43 lesions
STANDARD_DEVIATION 7.12 • n=5 Participants
|
|
T1 Hypointense Lesions Volume at Baseline
|
0.94 cm^3
STANDARD_DEVIATION 1.77 • n=5 Participants
|
0.84 cm^3
STANDARD_DEVIATION 1.50 • n=7 Participants
|
0.89 cm^3
STANDARD_DEVIATION 1.64 • n=5 Participants
|
|
T2 Lesions Volume at Baseline
|
5.51 cm^3
STANDARD_DEVIATION 7.17 • n=5 Participants
|
5.35 cm^3
STANDARD_DEVIATION 7.97 • n=7 Participants
|
5.44 cm^3
STANDARD_DEVIATION 7.55 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0, latest scan at month 24, 36 or early termination visitPopulation: Treated population of participants who had both a baseline MRI and an MRI at least one of the three during study time frames. The latest MRI was used if more than one during study MRI was available.
Results represent the database as of January 29, 2009. Brain volume was measured at baseline and at months 24, 36 and at early termination visits by magnetic resonance imaging (MRI). Brain atrophy was measured by comparing the change in brain volume from baseline to the latest scan at the three during study timeframes. SIENA is a fully automated method of analyzing longitudinal brain change. Adjusted (least square) mean values are presented.
Outcome measures
| Measure |
GA + Placebo
n=105 Participants
Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily.
|
GA + Prednisone
n=84 Participants
Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.
|
|---|---|---|
|
Percent Change From Baseline to Termination in Normalized Brain Volume Measured According to the SIENA (Structural Imaging Evaluation Using Normalization of Atrophy) Method
|
-0.46 percent change of baseline brain volume
Standard Error 0.088
|
-0.43 percent change of baseline brain volume
Standard Error 0.106
|
SECONDARY outcome
Timeframe: Months 12, 24, and 36Population: Treated population who had at least a 12 month MRI
Results represent the database as of January 29, 2009. Enhancing lesions are lesions that show inflammation on an MRI and are assumed to be new lesions. The sum of enhancing lesions observed in MRIs taken at months 12, 24 and 36 are offered.
Outcome measures
| Measure |
GA + Placebo
n=155 Participants
Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily.
|
GA + Prednisone
n=143 Participants
Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.
|
|---|---|---|
|
Cumulative Number of Enhancing Lesions at Months 12, 24 and 36
|
0.69 lesions
Standard Deviation 3.28
|
0.76 lesions
Standard Deviation 1.86
|
SECONDARY outcome
Timeframe: Day 0, Month 36 or the early termination visitPopulation: Treated population of participants with an MRI at the stated time frames.
Results represent the database as of January 29, 2009. The difference in T2 brain lesion volume as observed in MRIs from baseline to Month 36 or the early termination visit. T2 lesions are hyperintense lesions meaning that they appear as bright spots on the MRI image. These tend to show the total number of lesions and disease burden.
Outcome measures
| Measure |
GA + Placebo
n=58 Participants
Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily.
|
GA + Prednisone
n=51 Participants
Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.
|
|---|---|---|
|
Change From Baseline to Month 36 or Early Termination Visit in Volume of T2-Lesions
|
0.07 cm^3
Standard Deviation 3.21
|
0.09 cm^3
Standard Deviation 2.93
|
SECONDARY outcome
Timeframe: Day 0, Month 36 or early termination visitPopulation: Treated population of participants with an MRI at the stated time frames.
Results represent the database as of January 29, 2009. The difference in hypointense brain lesion volume as observed in MRIs from baseline to Month 36 or the early termination visit. Hypointense lesions display as dark areas on the MRI image, and represent areas of permanent axonal damage.
Outcome measures
| Measure |
GA + Placebo
n=58 Participants
Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily.
|
GA + Prednisone
n=51 Participants
Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.
|
|---|---|---|
|
Change From Baseline to Month 36 or Early Termination Visit in Volume of Hypointense Lesions
|
0.43 cm^3
Standard Deviation 1.60
|
0.17 cm^3
Standard Deviation 0.86
|
Adverse Events
GA + Placebo
Serious events: 16 serious events
Other events: 131 other events
Deaths: 0 deaths
GA + Prednisone
Serious events: 13 serious events
Other events: 151 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GA + Placebo
n=199 participants at risk
Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily.
|
GA + Prednisone
n=209 participants at risk
Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.
|
|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Eye disorders
Blindness
|
0.50%
1/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
General disorders
Death
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
General disorders
Pyrexia
|
0.00%
0/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
General disorders
Chest pain
|
0.50%
1/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Infections and infestations
Cellulitis
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Infections and infestations
Mastoiditis
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Infections and infestations
Otitis media
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Infections and infestations
Influenza
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Infections and infestations
Urosepsis
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Infections and infestations
Staphylococcal infection
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Injury, poisoning and procedural complications
Closed head injury
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Investigations
Heart rate increased
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Musculoskeletal and connective tissue disorders
Sensation of heaviness
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Nervous system disorders
Aphasia
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Nervous system disorders
Syncope
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Nervous system disorders
Grand mal convulsion
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Nervous system disorders
Headache
|
0.00%
0/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Nervous system disorders
Multiple sclerosis
|
1.0%
2/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Nervous system disorders
Convulsion
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Nervous system disorders
Tremor
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Psychiatric disorders
Suicidal ideation
|
0.50%
1/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
Other adverse events
| Measure |
GA + Placebo
n=199 participants at risk
Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily.
|
GA + Prednisone
n=209 participants at risk
Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.
|
|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Blood and lymphatic system disorders
Anaemia
|
1.0%
2/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Cardiac disorders
Palpitations
|
0.50%
1/199 • Day 1 through month 36
|
2.4%
5/209 • Day 1 through month 36
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/199 • Day 1 through month 36
|
2.9%
6/209 • Day 1 through month 36
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Congenital, familial and genetic disorders
Colour blindness
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Ear and labyrinth disorders
Motion sickness
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Ear and labyrinth disorders
Tinnitis
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Ear and labyrinth disorders
Vertigo
|
1.0%
2/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Endocrine disorders
Goitre
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Endocrine disorders
Thyroid disorder
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Endocrine disorders
Hyperthyroidism
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Endocrine disorders
Hypothyroidism
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Eye disorders
Blindness
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Eye disorders
Cataract
|
0.50%
1/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Eye disorders
Dry eye
|
1.0%
2/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Eye disorders
Lacrimation increased
|
0.50%
1/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Eye disorders
Madarosis
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Eye disorders
Eye pain
|
0.00%
0/199 • Day 1 through month 36
|
1.9%
4/209 • Day 1 through month 36
|
|
Eye disorders
Eye allergy
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Eye disorders
Eye irritation
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Eye disorders
Ocular hyperaemia
|
1.0%
2/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Eye disorders
Asthenopia
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Eye disorders
Optic atrophy
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Eye disorders
Pupillary reflex impaired
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Eye disorders
Macular cyst
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Eye disorders
Diplopia
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Eye disorders
Vision blurred
|
0.50%
1/199 • Day 1 through month 36
|
4.3%
9/209 • Day 1 through month 36
|
|
Eye disorders
Visual disturbance
|
0.00%
0/199 • Day 1 through month 36
|
1.4%
3/209 • Day 1 through month 36
|
|
Gastrointestinal disorders
Abdominal hernia
|
1.0%
2/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Gastrointestinal disorders
Toothache
|
1.0%
2/199 • Day 1 through month 36
|
1.4%
3/209 • Day 1 through month 36
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Gastrointestinal disorders
Diarrhoea
|
4.0%
8/199 • Day 1 through month 36
|
6.7%
14/209 • Day 1 through month 36
|
|
Gastrointestinal disorders
Dyspepsia
|
2.5%
5/199 • Day 1 through month 36
|
7.7%
16/209 • Day 1 through month 36
|
|
Gastrointestinal disorders
Epigastic discomfort
|
0.00%
0/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Gastrointestinal disorders
Gastritis
|
1.0%
2/199 • Day 1 through month 36
|
2.4%
5/209 • Day 1 through month 36
|
|
Gastrointestinal disorders
Abdominal pain
|
1.5%
3/199 • Day 1 through month 36
|
2.4%
5/209 • Day 1 through month 36
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.0%
2/199 • Day 1 through month 36
|
3.3%
7/209 • Day 1 through month 36
|
|
Gastrointestinal disorders
Constipation
|
0.50%
1/199 • Day 1 through month 36
|
1.4%
3/209 • Day 1 through month 36
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.0%
2/199 • Day 1 through month 36
|
2.9%
6/209 • Day 1 through month 36
|
|
Gastrointestinal disorders
Enteritis
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.50%
1/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Gastrointestinal disorders
Breath odour
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Gastrointestinal disorders
Dysphagia
|
1.0%
2/199 • Day 1 through month 36
|
1.4%
3/209 • Day 1 through month 36
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Gastrointestinal disorders
Gingivitis
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.50%
1/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Gastrointestinal disorders
Nausea
|
7.5%
15/199 • Day 1 through month 36
|
7.2%
15/209 • Day 1 through month 36
|
|
Gastrointestinal disorders
Vomiting
|
3.0%
6/199 • Day 1 through month 36
|
3.3%
7/209 • Day 1 through month 36
|
|
Gastrointestinal disorders
Haematochezia
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
1.0%
2/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Gastrointestinal disorders
Peritoneal lesion
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Gastrointestinal disorders
Stomatitis
|
0.50%
1/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
General disorders
Administration site reaction
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
General disorders
Asthenia
|
0.50%
1/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
General disorders
Fatigue
|
6.5%
13/199 • Day 1 through month 36
|
10.0%
21/209 • Day 1 through month 36
|
|
General disorders
Malaise
|
0.00%
0/199 • Day 1 through month 36
|
2.9%
6/209 • Day 1 through month 36
|
|
General disorders
Chills
|
0.50%
1/199 • Day 1 through month 36
|
2.4%
5/209 • Day 1 through month 36
|
|
General disorders
Peripheral coldness
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
General disorders
Pyrexia
|
3.0%
6/199 • Day 1 through month 36
|
2.4%
5/209 • Day 1 through month 36
|
|
General disorders
Gait disturbance
|
0.00%
0/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
General disorders
Chest discomfort
|
1.5%
3/199 • Day 1 through month 36
|
2.4%
5/209 • Day 1 through month 36
|
|
General disorders
Energy increased
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
General disorders
Feeling abnormal
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
General disorders
Feeling jittery
|
0.50%
1/199 • Day 1 through month 36
|
1.4%
3/209 • Day 1 through month 36
|
|
General disorders
Flushing
|
0.50%
1/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
General disorders
Hangover
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
General disorders
Influenza like illness
|
0.00%
0/199 • Day 1 through month 36
|
1.4%
3/209 • Day 1 through month 36
|
|
General disorders
Irritability
|
0.00%
0/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
General disorders
Swelling
|
0.00%
0/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
General disorders
Thirst
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
General disorders
Inflammation
|
1.0%
2/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
General disorders
Infusion site reaction
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
General disorders
Injection site bruising
|
0.50%
1/199 • Day 1 through month 36
|
1.4%
3/209 • Day 1 through month 36
|
|
General disorders
Injection site erythema
|
4.5%
9/199 • Day 1 through month 36
|
1.4%
3/209 • Day 1 through month 36
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
General disorders
Injection site induration
|
1.5%
3/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
General disorders
Injection site mass
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
General disorders
Injection site nodule
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
General disorders
Injection site pain
|
1.5%
3/199 • Day 1 through month 36
|
2.9%
6/209 • Day 1 through month 36
|
|
General disorders
Injection site pruritus
|
2.5%
5/199 • Day 1 through month 36
|
1.4%
3/209 • Day 1 through month 36
|
|
General disorders
Injection site reaction
|
4.0%
8/199 • Day 1 through month 36
|
3.8%
8/209 • Day 1 through month 36
|
|
General disorders
Injection site swelling
|
1.0%
2/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
General disorders
Injection site urticaria
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
General disorders
Cyst
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
General disorders
Face oedema
|
0.00%
0/199 • Day 1 through month 36
|
1.9%
4/209 • Day 1 through month 36
|
|
General disorders
Generalised oedema
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
General disorders
Oedema
|
0.00%
0/199 • Day 1 through month 36
|
1.9%
4/209 • Day 1 through month 36
|
|
General disorders
Oedema peripheral
|
1.5%
3/199 • Day 1 through month 36
|
2.4%
5/209 • Day 1 through month 36
|
|
General disorders
Chest pain
|
0.00%
0/199 • Day 1 through month 36
|
2.4%
5/209 • Day 1 through month 36
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
General disorders
Pain
|
1.0%
2/199 • Day 1 through month 36
|
5.7%
12/209 • Day 1 through month 36
|
|
General disorders
Adverse drug reaction
|
0.50%
1/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
General disorders
Idiosyncratic drug reaction
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Immune system disorders
Allergy to animal
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Immune system disorders
Hypersensitivity
|
0.50%
1/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Immune system disorders
Drug hypersensitivity
|
0.50%
1/199 • Day 1 through month 36
|
1.4%
3/209 • Day 1 through month 36
|
|
Immune system disorders
Food allergy
|
0.50%
1/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/199 • Day 1 through month 36
|
1.4%
3/209 • Day 1 through month 36
|
|
Infections and infestations
Gastric infection
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Infections and infestations
Gastroenteritis
|
1.0%
2/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Infections and infestations
Bacteriuria
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Infections and infestations
Cellulitis
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Infections and infestations
Vaginitis bacterial
|
1.0%
2/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Infections and infestations
Candidiasis
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Infections and infestations
Oral candidiasis
|
1.0%
2/199 • Day 1 through month 36
|
1.4%
3/209 • Day 1 through month 36
|
|
Infections and infestations
Coxsackie viral infection
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Infections and infestations
Tooth abscess
|
1.5%
3/199 • Day 1 through month 36
|
1.4%
3/209 • Day 1 through month 36
|
|
Infections and infestations
Tooth infection
|
1.0%
2/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Infections and infestations
Ear infection
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Infections and infestations
Otitis externa
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Infections and infestations
Otitis media
|
0.50%
1/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Infections and infestations
Conjunctivitis infective
|
1.0%
2/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Infections and infestations
Eye infection
|
2.0%
4/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Infections and infestations
Fungal infection
|
1.0%
2/199 • Day 1 through month 36
|
1.4%
3/209 • Day 1 through month 36
|
|
Infections and infestations
Onychomycosis
|
1.0%
2/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/199 • Day 1 through month 36
|
1.9%
4/209 • Day 1 through month 36
|
|
Infections and infestations
Herpes simplex
|
1.5%
3/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Infections and infestations
Herpes simplex ophthalmic
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Infections and infestations
Herpes zoster
|
0.50%
1/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Infections and infestations
Localised infection
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Infections and infestations
Influenza
|
2.5%
5/199 • Day 1 through month 36
|
2.9%
6/209 • Day 1 through month 36
|
|
Infections and infestations
Bronchitis
|
6.5%
13/199 • Day 1 through month 36
|
2.4%
5/209 • Day 1 through month 36
|
|
Infections and infestations
Bronchitis acute
|
0.50%
1/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Infections and infestations
Bronchitis chronic
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Infections and infestations
Lower respiratory tract infection
|
1.0%
2/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Infections and infestations
Pneumonia
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Infections and infestations
Mycoplasma infection
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Infections and infestations
Eczema infected
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Infections and infestations
Skin infection
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/199 • Day 1 through month 36
|
1.9%
4/209 • Day 1 through month 36
|
|
Infections and infestations
Pharyngitis streptococcal
|
1.0%
2/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Infections and infestations
Tinea infection
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Infections and infestations
Acute sinusitis
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Infections and infestations
Nasopharyngitis
|
9.5%
19/199 • Day 1 through month 36
|
10.5%
22/209 • Day 1 through month 36
|
|
Infections and infestations
Pharyngitis
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Infections and infestations
Sinusitis
|
5.0%
10/199 • Day 1 through month 36
|
7.7%
16/209 • Day 1 through month 36
|
|
Infections and infestations
Upper respiratory tract infection
|
6.0%
12/199 • Day 1 through month 36
|
12.0%
25/209 • Day 1 through month 36
|
|
Infections and infestations
Cystitis
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Infections and infestations
Pyelonephritis
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Infections and infestations
Urinary tract infection
|
7.5%
15/199 • Day 1 through month 36
|
11.0%
23/209 • Day 1 through month 36
|
|
Infections and infestations
Bronchitis viral
|
0.50%
1/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Infections and infestations
Gastroenteritis viral
|
1.5%
3/199 • Day 1 through month 36
|
1.4%
3/209 • Day 1 through month 36
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Infections and infestations
Viral sinusitis
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Injury, poisoning and procedural complications
Caustic injury
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Injury, poisoning and procedural complications
Injection site reaction
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Injury, poisoning and procedural complications
Injection site urticaria
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.50%
1/199 • Day 1 through month 36
|
2.4%
5/209 • Day 1 through month 36
|
|
Injury, poisoning and procedural complications
Rotator cuff syndrome
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.50%
1/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.50%
1/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Injury, poisoning and procedural complications
Fall
|
1.0%
2/199 • Day 1 through month 36
|
3.3%
7/209 • Day 1 through month 36
|
|
Injury, poisoning and procedural complications
Accidental needle stick
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.0%
2/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.50%
1/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Injury, poisoning and procedural complications
Contusion
|
1.5%
3/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Investigations
Blood glucose increased
|
0.50%
1/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Investigations
Cardiac murmur
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Investigations
Blood cholesterol increased
|
2.0%
4/199 • Day 1 through month 36
|
1.4%
3/209 • Day 1 through month 36
|
|
Investigations
Heart rate decreased
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Investigations
Heart rate increased
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Investigations
Alanine aminotransferase increased
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Investigations
Blood uric acid increased
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Investigations
Urine ketone body present
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Investigations
Blood potassium increased
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Investigations
Body temperature fluctuations
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Investigations
Breath sounds abnormal
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Investigations
Weight increased
|
1.5%
3/199 • Day 1 through month 36
|
3.3%
7/209 • Day 1 through month 36
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.50%
1/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Investigations
Protein total increased
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Investigations
Blood testosterone decreased
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Investigations
Protein urine
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Investigations
Urine analysis abnormal
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Investigations
Urine leukocyte esterase positive
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Investigations
White blood cells urine positive
|
0.50%
1/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Investigations
Blood pressure increased
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Investigations
Herpes simplex serology positive
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Investigations
Vitamin D decreased
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Investigations
White blood cell count increased
|
0.50%
1/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Metabolism and nutrition disorders
Appetite disorder
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.50%
1/199 • Day 1 through month 36
|
1.4%
3/209 • Day 1 through month 36
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.50%
1/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Metabolism and nutrition disorders
Diabetes mellitus non-insulin-dependent
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.0%
2/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.50%
1/199 • Day 1 through month 36
|
1.9%
4/209 • Day 1 through month 36
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.50%
1/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Metabolism and nutrition disorders
Gout
|
0.50%
1/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/199 • Day 1 through month 36
|
2.9%
6/209 • Day 1 through month 36
|
|
Metabolism and nutrition disorders
Oedema
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.50%
1/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Musculoskeletal and connective tissue disorders
Bone cyst
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.50%
1/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Musculoskeletal and connective tissue disorders
Joint contracture
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.0%
8/199 • Day 1 through month 36
|
5.3%
11/209 • Day 1 through month 36
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Musculoskeletal and connective tissue disorders
Loose body in joint
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/199 • Day 1 through month 36
|
1.9%
4/209 • Day 1 through month 36
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.0%
2/199 • Day 1 through month 36
|
4.3%
9/209 • Day 1 through month 36
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.5%
9/199 • Day 1 through month 36
|
4.3%
9/209 • Day 1 through month 36
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
1.0%
2/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Musculoskeletal and connective tissue disorders
Myokymia
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.0%
2/199 • Day 1 through month 36
|
2.9%
6/209 • Day 1 through month 36
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.5%
3/199 • Day 1 through month 36
|
1.9%
4/209 • Day 1 through month 36
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
1.0%
2/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.0%
4/199 • Day 1 through month 36
|
1.9%
4/209 • Day 1 through month 36
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.5%
7/199 • Day 1 through month 36
|
5.3%
11/209 • Day 1 through month 36
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
1.0%
2/199 • Day 1 through month 36
|
1.4%
3/209 • Day 1 through month 36
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Musculoskeletal and connective tissue disorders
Axillary mass
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.50%
1/199 • Day 1 through month 36
|
1.4%
3/209 • Day 1 through month 36
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cyst
|
0.00%
0/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Teratoma
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip neoplasm
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Abdominal neoplasm
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cyst
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Nervous system disorders
Carotid artery aneurysm
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Nervous system disorders
Balance disorder
|
0.50%
1/199 • Day 1 through month 36
|
1.9%
4/209 • Day 1 through month 36
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Nervous system disorders
Nystagmus
|
1.0%
2/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Nervous system disorders
Lethargy
|
0.50%
1/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Nervous system disorders
Loss of consciousness
|
1.0%
2/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Nervous system disorders
Somnolence
|
1.0%
2/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Nervous system disorders
Syncope vasovagal
|
0.00%
0/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Nervous system disorders
Circadian rhythm sleep disorder
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Nervous system disorders
Hyperkinesia
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.50%
1/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Nervous system disorders
Headache
|
7.0%
14/199 • Day 1 through month 36
|
14.8%
31/209 • Day 1 through month 36
|
|
Nervous system disorders
Sinus headache
|
0.50%
1/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Nervous system disorders
Sciatica
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Nervous system disorders
Amnesia
|
0.50%
1/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/199 • Day 1 through month 36
|
2.9%
6/209 • Day 1 through month 36
|
|
Nervous system disorders
Migraine
|
3.0%
6/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Nervous system disorders
Multiple sclerosis
|
1.0%
2/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Nervous system disorders
Hypertonia
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Nervous system disorders
Dizziness
|
5.5%
11/199 • Day 1 through month 36
|
5.7%
12/209 • Day 1 through month 36
|
|
Nervous system disorders
Myoclonus
|
1.0%
2/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Nervous system disorders
Muscle spasticity
|
2.0%
4/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Nervous system disorders
Optic neuritis
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Nervous system disorders
Burning sensation
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Nervous system disorders
Dysaesthesia
|
0.50%
1/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Nervous system disorders
Hypoaesthesia
|
3.0%
6/199 • Day 1 through month 36
|
3.3%
7/209 • Day 1 through month 36
|
|
Nervous system disorders
Hypoaesthesia oral
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Nervous system disorders
Lhermitte's sign
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Nervous system disorders
Paraesthesia
|
3.0%
6/199 • Day 1 through month 36
|
4.3%
9/209 • Day 1 through month 36
|
|
Nervous system disorders
Diplegia
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Nervous system disorders
Convulsion
|
0.00%
0/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Nervous system disorders
Dysgeusia
|
1.0%
2/199 • Day 1 through month 36
|
2.9%
6/209 • Day 1 through month 36
|
|
Nervous system disorders
Loss of proprioception
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Nervous system disorders
Neuralgia
|
1.5%
3/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Nervous system disorders
Restless leg syndrome
|
0.50%
1/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Nervous system disorders
Radicular pain
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Nervous system disorders
Tremor
|
2.5%
5/199 • Day 1 through month 36
|
2.9%
6/209 • Day 1 through month 36
|
|
Pregnancy, puerperium and perinatal conditions
Abortion
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Pregnancy, puerperium and perinatal conditions
Unintended pregnancy
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Psychiatric disorders
Affect lability
|
1.0%
2/199 • Day 1 through month 36
|
1.9%
4/209 • Day 1 through month 36
|
|
Psychiatric disorders
Agitation
|
0.00%
0/199 • Day 1 through month 36
|
1.4%
3/209 • Day 1 through month 36
|
|
Psychiatric disorders
Anxiety
|
2.0%
4/199 • Day 1 through month 36
|
4.3%
9/209 • Day 1 through month 36
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Psychiatric disorders
Stress
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Psychiatric disorders
Tension
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Psychiatric disorders
Attention deficit/hyperactivity disorder
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Psychiatric disorders
Aggression
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Psychiatric disorders
Irritability
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Psychiatric disorders
Disorientation
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Psychiatric disorders
Depression
|
5.0%
10/199 • Day 1 through month 36
|
4.3%
9/209 • Day 1 through month 36
|
|
Psychiatric disorders
Insomnia
|
11.1%
22/199 • Day 1 through month 36
|
21.1%
44/209 • Day 1 through month 36
|
|
Psychiatric disorders
Anger
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/199 • Day 1 through month 36
|
1.4%
3/209 • Day 1 through month 36
|
|
Psychiatric disorders
Mood swings
|
0.50%
1/199 • Day 1 through month 36
|
1.4%
3/209 • Day 1 through month 36
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Psychiatric disorders
Depressed mood
|
1.0%
2/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Psychiatric disorders
Panic disorder
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Psychiatric disorders
Abnormal dreams
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Psychiatric disorders
Illusion
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Psychiatric disorders
Claustrophobia
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Psychiatric disorders
Speech disorder
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Psychiatric disorders
Bruxism
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/199 • Day 1 through month 36
|
1.4%
3/209 • Day 1 through month 36
|
|
Renal and urinary disorders
Dysuria
|
0.50%
1/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Renal and urinary disorders
Micturition urgency
|
0.50%
1/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Renal and urinary disorders
Pollakiuria
|
0.50%
1/199 • Day 1 through month 36
|
2.9%
6/209 • Day 1 through month 36
|
|
Renal and urinary disorders
Stress incontinence
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Renal and urinary disorders
Urinary incontinence
|
1.0%
2/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Renal and urinary disorders
Urinary retention
|
1.0%
2/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Renal and urinary disorders
Neurogenic bladder
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.50%
1/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Renal and urinary disorders
Haematuria
|
1.0%
2/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Renal and urinary disorders
Proteinuria
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Reproductive system and breast disorders
Breast disorder
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Reproductive system and breast disorders
Hot flush
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Reproductive system and breast disorders
Ovarian mass
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Reproductive system and breast disorders
Sexual dysfunction
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Reproductive system and breast disorders
Uterine mass
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Reproductive system and breast disorders
Genital pruritus female
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.5%
3/199 • Day 1 through month 36
|
4.8%
10/209 • Day 1 through month 36
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
4/199 • Day 1 through month 36
|
3.3%
7/209 • Day 1 through month 36
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal erythema
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.5%
5/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.5%
3/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
1.0%
2/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.50%
1/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
1.0%
2/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
3.5%
7/199 • Day 1 through month 36
|
4.3%
9/209 • Day 1 through month 36
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.0%
2/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Respiratory, thoracic and mediastinal disorders
Sinus headache
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/199 • Day 1 through month 36
|
3.8%
8/209 • Day 1 through month 36
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.5%
3/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.50%
1/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Skin and subcutaneous tissue disorders
Hypoaesthesia facial
|
0.50%
1/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Skin and subcutaneous tissue disorders
Skin warm
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.50%
1/199 • Day 1 through month 36
|
2.9%
6/209 • Day 1 through month 36
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.50%
1/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Skin and subcutaneous tissue disorders
Lipoatrophy
|
1.5%
3/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.5%
5/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
1.0%
2/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.0%
4/199 • Day 1 through month 36
|
5.7%
12/209 • Day 1 through month 36
|
|
Skin and subcutaneous tissue disorders
Subcutaneous nodule
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Skin and subcutaneous tissue disorders
Scar
|
0.50%
1/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.0%
4/199 • Day 1 through month 36
|
0.96%
2/209 • Day 1 through month 36
|
|
Social circumstances
Alcohol use
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Surgical and medical procedures
Tooth extraction
|
1.0%
2/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Surgical and medical procedures
Inguinal hernia repair
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Surgical and medical procedures
Thyroid operation
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Surgical and medical procedures
Uterine dilation and curettage
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Surgical and medical procedures
Uterine prolapse repair
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Vascular disorders
Aortic arteriosclerosis
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Vascular disorders
Haematoma
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Vascular disorders
Flushing
|
1.5%
3/199 • Day 1 through month 36
|
7.2%
15/209 • Day 1 through month 36
|
|
Vascular disorders
Hot flush
|
0.00%
0/199 • Day 1 through month 36
|
0.48%
1/209 • Day 1 through month 36
|
|
Vascular disorders
Femoral arterial stenosis
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Vascular disorders
Hypertension
|
2.0%
4/199 • Day 1 through month 36
|
2.4%
5/209 • Day 1 through month 36
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
|
Reproductive system and breast disorders
Vaginal ulceration
|
0.50%
1/199 • Day 1 through month 36
|
0.00%
0/209 • Day 1 through month 36
|
Additional Information
Director, Clinical Research
Teva Branded Pharmaceutical Products, R&D Inc.
Phone: 215-591-3000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
- Publication restrictions are in place
Restriction type: OTHER